Saint Agnes Medical Center

“COMPLIANCE WITH LAWS CFR(s): 482.11 Compliance with Federal, State and Local Laws This Condition is not met as evidenced by: 45929 Based on observation, interview and record review, the Condition of Participation (COP) Compliance with Federal, State, and Local laws and regulations related to the health and safety of patients was determined to be NOT MET when the hospital failed to follow California state requirements on reporting of adverse events for two of two patients, Patient 1 and Patient 4, when: 1. Patient (Pt) 1 a 38-year-old unexpectedly died within 24 hours of induction of anesthesia for surgery on 7/14/25. (Refer to A021, Finding 1) 2. A pregnant woman (Pt 4) was not identified as having Group B Streptococcus infection (GBS - a common bacterium that is usually harmless for adults, but can cause serious illness or death to newborns) during her hospital stay and was not educated on signs and symptoms of infant early onset or late onset GBS. (Refer to A021, Finding 1) The cumulative effect of this systemic failure resulted in the facility’s substantial noncompliance with federal, state and local laws. (Refer A022)”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to protect and promote each patient’s right to care in a safe setting for one of five newborn patients, Patient (Pt) 5, when Pt 4, mother of Pt 5, was not identified or treated for Group B Streptococcus infection (GBS - a common bacteria that is usually harmless for adults, but can cause serious illness or death to newborns) and Pt 5 was discharged untreated and no education was given to mother of Pt 5 for signs and symptoms of infection. Nurses and the pediatrician were aware of the possible serious complications from GBS to Pt 5 and did not make sufficient effort to determine the status of Pt 4’s GBS laboratory results prior to discharge. As a result of these failures, Pt 5 developed fever and decreased appetite and was treated at a local hospital that specialized in the care of pediatric patients and died as a result of an avoidable GBS infection at three weeks of age. (Refer to A144) The cumulative effect of these systemic failures resulted in the hospital’s inability to provide quality care in a safe setting.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 37529 Based on observations, interview and record review, the hospital failed to have an organized medical staff responsible for the quality of medical care provided to patients when: 1. Eight of eight Allied Health Professionals (AHP), Perfusionists (A highly trained medical professional who operates the heart-lung machine and other specialized equipment during cardiac surgery, ensuring the patient’s circulatory and respiratory functions are maintained while a surgeon operated on the heart) 1, 2, 3, 4, 5, 6, 7, and 8, were not credentialed and privileged in accordance with the Medical Staff Bylaws, the Allied Health Professional (AHP) Manual, and California state law. (Refer to A 339) 2. 26 of 26 Pediatricians (doctors who specialize in the care of infants, children and adolescents; MDs 3, 6, 7, 8, 9, 10,11,12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30) did not have a periodic appraisal of their professional performance in accordance the Medical Staff Rules and Regulations and policies. (Refer to A 340) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure quality care in a safe and effective manner.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 47205 Based on interview and record review, the nursing staff failed to provide quality care in accordance with hospital policies and procedures when: 1. Nursing staff failed to recognize and assess the early signs and symptoms of an acute stroke (a sudden loss of blood circulation to an area of the brain) for one of three sampled patients, Patient (Pt) 2, in accordance with professional practice standards. This failure resulted in delayed response and management of the change in Pt 2 ’ s medical condition. (Refer to A398, Finding 1) . 2. The facility nursing staff failed to complete and document a Rapid Response Team (RRT-a hospital steam d respond to patients with early signs of clinical deterioration) call in the Electronic Medical Record (EMR- a digital version of a patient’s paper chart, containing medical and treatment information) from the bedside nurses for one of three sampled patients, Pt 2, in accordance with hospital P&Ps titled “Rapid Response Team (RRT),” dated 4/2023, and “Rapid Response Team Standardized Procedure” dated 4/11/25. These failures resulted in Pt 2’s identified change of condition to not be readily available to care providers to use in further assessments and possibly negatively affecting Pt 2’s care. (Refer to A398, Finding 2) 3. Nursing staff failed to remove an armband from one patient prior to applying a long-arm splint in the Emergency Department (ED) in accordance with professional practice standards. This failure caused discomfort for Pt 3 and required another visit to an emergency department, and had the potential to cause a pressure injury from the armband, which could cause an infection, and could have cut off blood flow to Pt 3’s hand and possibly causing loss of function of his hand. (Refer to A398, Finding 3) The cumulative effect of these systemic failures resulted in the hospital’s inability to provide quality care in a safe setting.”

“COMPLIANCE WITH LAWS CFR(s): 482.11(a) The hospital must be in compliance with applicable Federal laws related to the health and safety of patients. This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to follow California state requirements on reporting of adverse events for two of two patients, Patient 1 and Patient 4, when: 1. Patient (Pt) 1 a 38-year-old unexpectedly died within 24 hours of induction of anesthesia for surgery on 7/14/25 and reporting requirements for Health and Safety Code (HSC) 1279.1 (b) 7 were not followed. This failure had the potential for further reportable events to go unreported and potential harm to other patients. 2. A pregnant woman (Pt 4) was not identified as having GBS (GBS - a common bacterium that is usually harmless for adults, but can cause serious illness or death to newborns) during her hospital stay and was not educated on signs and symptoms of infant early onset or late onset GBS and lab values were not followed up and the baby’s death was not reported as an unusual event in accordance with HSC. This failure resulted in Pt 4 not recognizing irritability and vomiting as symptoms of GBS meningitis and not seeking emergency treatment until the infant (Pt 5) was critically ill and died on 5/29/25. Findings: 1. During a review of Pt 1’s “History & Physical (H&P)”, dated 7/14/25, the H&P indicated pt 1 was a 38 year old female with a past medical history of bariatric surgery (weight loss surgery) who came to the hospital on 7/14/25 for complaint of endometriosis (a disease in which tissue similar to the lining of the uterus grows outside the uterus) and underwent an elective laparoscopic hysterectomy (minimally invasive surgical procedure to remove the uterus through small incisions in the abdomen). The H&P indicated Pt 1 became hypoxic (having a low oxygen level) and hypotensive (having a low blood pressure) during the procedure. The H&P indicated the procedure was stopped, a code blue (term used to indicate a patient requires resuscitation or is in need of immediate medical attention) was called, and cardiopulmonary resuscitation (CPR, chest compressions and rescue breaths) was started. The H&P indicated tissue plasminogen activator (tPA, a medication to dissolve blood clots) due to suspected pulmonary embolism (PE, a serious condition where a blood clot usually originating in a deep vein of the leg, travels to the lungs and blocks the pulmonary artery which reduces oxygen level in the body and can lead to death). The H&P indicated after 40 minutes of CPR, a pulse was achieved but Pt 1’s pupils were dilated and unresponsive to light (a sign of serious brain injury). The H&P indicated a chest x-ray was performed with findings consistent with PE. The H&P indicated Pt 1 was the taken to the Critical Care Unit at 12:20 p.m. The H&P indicated Pt 1’s family agreed to no further escalation of care and to proceed with comfort care (medical care to relieve suffering and improve quality of life for individual facing life-limiting illness) and Pt 1 passed away at 12:54 p.m. on 7/14/25. During a review of Pt 1’s “Interoperative Report (IR)”, dated 7/14/25, the IR indicated Pt 1 was brought to the operating room (OR) at 9:56 a.m. and was out of the OR at 12:04 p.m. During a review of Pt 1’s “Anesthesia Preprocedure Evaluation (APE)”, date 7/14/25, the APE indicated, “ ... Relevant Problems No relevant problems ... Clinical information reviewed: Tobacco/Allergies/Meds [medications]/Med Hx [medical history]/Surg Hx [surgical history]/OB Status [obstetrical, related to childbirth]/Fam Hx [family history]/Soc Hx [ social history] ... Anesthesia Plan ... ASA 2 [American Society of Anesthesiologists’ classification of physical health and predict their risk during surgery, ranging from ASA 1: a healthy patient with no systemic disease to ASA 5: patient is near death and not expected to survive 24 hours). During an interview on 7/30/25 at 2:05 p.m. with Medical Doctor (MD) 1, MD 1 stated she attempted to perform the surgery on Pt 1 on 7/14/25. MD 1 stated moments after the surgery started Pt 1 became hypoxic (low oxygen level) followed by bradycardia (slow heart rate) and hypotension (low blood pressure). MD 1 stated CPR was initiated immediately. MD 1 stated after a pulse was achieved, Pt 1’s pupils were fixed and dilated. MD 1 stated Pt 1’s medical history did not suggest any risk for anesthesia or surgery and Pt 1’s death was unexpected. MD 1 stated she has been practicing for over 25 years and has never seen this happen before. During an interview on 7/30/25 at 3:10 p.m. with Certified Registered Nurse Anesthetist (CRNA) 1, CRNA 1 stated she met with Pt 1 prior to surgery and Pt 1 told CRNA 1 she did not have hypertension or take any medications for hypertension. CRNA 1 stated Pt 1 had a gastric bypass two years ago. CRNA 1 stated Pt 1’s BMI (Bass Mass Index, a calculated measure of weight relative to height, normal considered 18.5 to 24.9) was 29. CRNA 1 stated she listed Pt 1 as an ASA 2 because she had no systemic disease (a condition that affects multiple organ systems or the entire body). During a review of the hospital’s “Adverse Event List (AEL)”, dated 7/2025, the AEL indicated Pt 1’s death as, “ ... General Event type: Surgery/procedure ... Specific Event Type: Death following/during surgery/invasive procedure ... Severity level: 1 - event has the capacity to cause error ...”. During an interview on 7/31/25 at 1:18 p.m. with the Patient Safety Officer (PSO), the PSO stated a Critical Event Review Team (CERT) met the afternoon of Pt 1’s death. The PSO stated the CERT consisted of the President & Market Leader (PML), Chief Nursing Officer (CNO), Chief Medical Officer (CMO), and other Senior Leadership (other Chief Officers). The PSO stated the team involved in Pt 1’s surgery and resuscitation were included to put together a timeline of the event. The PSO stated the PML, CNO, CMO, and Senior Leadership met to identify potential gaps and review criteria for reporting the event to Californis Department of Public Health (CDPH). The PSO stated criteria for reporting a death after surgery was for a normal healthy patient. The PSO stated the CERT team decided to “ ... put a pin in it ....” and meet the following day. The PSO stated the meeting for the decision not to report was closed to only Senior Leadership. The PSO stated Pt 1 had a history of gastric bypass, arthritis, abdominal pain, multiple surgeries, and was “in and out of the ED [Emergency Department] ...”. When asked if someone with a gastric bypass, arthritis and previous surgeries should expect to die when having a hysterectomy, the PSO stated “ ... no ...”. During a concurrent interview and record review on 7/31/25 at 2:10 p.m. with the PSO and Clinical Risk Manager (RM) 1 and RM 2, Pt 1’s “Root Cause Analysis (RCA, a systematic process used to investigate the fundamental causes of adverse events)” was reviewed. The PSO stated the [Hospital’s parent Company’s] Safety Event Decision Algorithm determined practice did not deviate from standards so there was no safety event to report to parent company. PSO stated the only blood pressure completed on Pt 1 prior to surgery was normal. RM 1 stated the RCA indicated, “... Reporting to CDPH- discussed patient’s complex history including 2 prior bariatric Sx [surgeries], HTN [hypertension], determined to be not reportable ...”. During an interview on 8/1/25 at 11:35 a.m. with the PML, the PML stated pt 1 was not a normal healthy patient and that is why the hospital did not report the death to CDPH. The PML agreed a normal healthy patient would not be in the hospital. During the review of a professional reference titled, “Statement on ASA Physical Status Classification System (SASA), dated 12/13/20, the SASA indicated, “ ... Current Definitions ... ASA I ...A normal healthy patient ... example ... Healthy, non-smoking, no or minimal alcohol use ... ASA II ... A patient with mild systemic disease ... example ... Mild disease only without substantive functional limitations ... obesity (30< BMI<40), well-controlled DM [diabetes]/HTN, mild lung disease ... ASA III ... A Patient with severe systemic disease ... examples ... Substantive functional limitations. One or more moderate to severe diseases, poorly controlled DM or HTN ...morbid obesity (BMI >40) ...”. During a review of Health and Safety Code section 1279.1, date unknown, the code indicated, “(a)A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law. (b)For purposes of this section, “adverse event” includes any of the following: (1)Surgical events, including the following:... (E)Death during or up to 24 hours after induction of anesthesia after surgery of a normal, healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance and for whom the pathologic processes for which the operation is to be performed are localized and do not entail a systemic disturbance....” 2. Background: Patient (Pt) 4 was a 32-year-old woman who was seen by her obstetrician (OB - doctor who cares for pregnant women and delivers babies) in a clinic on 5/5/25 when she was 38 weeks pregnant (full term is 39-40 weeks.) The OB tested Pt 4 for GBS. Pt 4 went into labor on 5/6/25 and went to the hospital. The hospital did not treat Pt 4 for GBS, and Pt 4 gave birth to a baby girl (Pt 5.) Pt 5 got sick with GBS meningitis and died 3 weeks after birth. During an interview on 7/29/25 at 10:35 a.m. with Registered Nurse (RN) 3, RN s stated, “Patients are usually identified as GBS positive in the doctor’s office, and we get a report. If not, we have the option of asking the doctor for an order for a “rapid GBS” which gives results in about 60 minutes. The pregnant patient is treated with Ampicillin IV every 4 hours if they are positive GBS. This reduces the risk for the baby.” During an interview on 7/29/25 at 10:45 a.m. with RN 4, RN 4 stated, “for GBS positive mothers, doctors usually treat with ampicillin 2 grams to start, then 1 gram every 4 hours until delivery. How they treat also depends on how long the mom has been ruptured (how long since her water broke). Once delivered, the nursery nurse cares for the baby. They do a sepsis workup on the baby.” During an interview on 7/29/25 at 10:55 a.m. with RN 5, RN 5 stated she works in the nursery caring for newborn babies. RN 5 stated, “ ... if mom (mother of baby) is GBS positive, we make sure mom got treated (with antibiotics for GBS). If not, the doctor will order a sepsis workup for the baby (tests to check for GBS infection). If the baby has a temperature, we call the doctor immediately.” During an interview on 7/29/25 at 11:10 a.m. with RN 6, RN 6 stated she is a postpartum nurse (a nurse who takes care of the mother and baby after the baby is delivered.) RN 6 stated, “if mom is GBS positive, we monitor the baby for signs of infection. We find out if mom was treated for greater than 4 hours with antibiotics. Most pediatricians keep the baby for 48 hours for monitoring if the mother was GBS positive.” During an interview on 7/29/25 at 11:20 a.m. with RN 7, RN 7 stated she is a post-partum nurse. RN 7 stated the nurses in Labor and Delivery tell the nurses in postpartum if the mother was GBS positive. The nursery nurse tells the pediatrician. They check the prenatal record to see if the mother was positive and to see if she has been treated with antibiotics. We usually observe the baby for 48 hours if the mom is GBS positive. During an interview and record review on 7/30/25 at 10:10 with the Assistant Director of Obstetrics (ADOB) and the Interim Manager (Mgr 5) of the Obstetrics Emergency Department (OBED), the ADOB opened the Electronic Medical Record (EMR) for Pt 4. The EMR indicated Pt 4 came into OBED on 5/7/25 at 12:51 a.m. and stayed in the OBED for 1 hour 18 minutes. At 1:29 a.m., the on-call Obstetrician (MD 4), called the OBED. Mgr 5 stated, “they were batching the phone calls.” Mgr 5 explained that “batching” means that all the nurses who need to talk to the on-call doctor tell one nurse what they need to ask the doctor about different patients, and one nurse relays all the information to the on-call doctor. The nurse (RN 8) who talked to MD 4 told him about Pt 4’s condition and told him that Pt 4 was GBS negative. Mgr 5 stated, “I don’t know where she got that information. She might have been confusing the patients. Nurses have been told not to batch calls, or at least not to report on other nurses’ assignments.” During a concurrent interview and record review on 7/30/25 at 5:10 p.m. with MD 3, MD 3 stated he is the pediatrician who discharged Pt 5. MD 3 stated he relies on the nursing documentation to determine if the mother of the baby is GBS positive, and the nursing notes indicated Pt 4 was GBS negative in the “Neonatal Sepsis Risk” (a scoring tool that determines how likely the newborn baby is to get a serious infection) note. MD 3 stated he does not look for a lab result to determine if the mother was GBS positive. MD 3 stated he was aware that there is a “rapid strep” test that can be done to determine if a mother is GBS positive if they do not know the status. MD 3 stated the test is called a PCR (Polymerase Chain Reaction - a testing method that yields results very quickly.) During a concurrent interview and record review on 7/30/25 at 5:25 p.m. with the ADOB, the ADOB opened the EMR for Pt 5 and reviewed the document titled “Neonatal Sepsis Risk” which indicated “Values Information ...taken by [RN 9] on 5/7/25 at 12:00, Recorded by [RN 9] on 5/7/25 at 12:18. “Maternal Group B Strep Status” indicated “2” which indicated Pt 4 was “negative” for GBS. The ADOB stated this information was entered by the nurse, and it isn’t a lab result. The ADOB stated, “I don’t know where she got that from. It’s a field that they enter manually, it doesn’t flow over from another area in the chart”. During a review of hospital document titled, “History and Physical” dated 5/8/25 at 7:33 a.m. by MD 3, the note indicated, “ ... Prenatal Labs: No results found for: ... GBS, GBSCX (GBS culture.) During a review of hospital document titled, “Discharge Summary” dated 5/8/25 at 7:33 a.m. by MD 3, the note indicated, “ ... Prenatal Labs: No results found for: ... GBS, GBSCX. During a concurrent interview and record review on 7/31/25 at 2:00 p.m. with RN 10, RN 10 reviewed her notes for Pt 5 in the EMR. RN 10 stated she works in postpartum where they are assigned “couplet care” which means they take care of both the mother and the baby. RN 10 stated she was the nurse assigned to Pt 4 and Pt 5 on the day the mother and baby were sent home from the hospital. RN 10 reviewed her note titled, “Chat Conversations about [Pt 4]” which indicated, “Sender: [RN 10] ‘hey, this couplet should be good to go ...” informing the discharge nurse that the mother and baby were ready to be discharged home. RN 10 stated, “I have a checklist that I use to make sure the mother and baby are ready to go.” RN 10 stated that she saw MD 3’s note that indicated there were no results for Pt 4’s GBS status, which told her that MD 3 was aware of this and was discharging anyway. RN 10 stated, “Not having the results back doesn’t necessarily stop the discharge. The doctor might plan to follow up with the mother and baby after discharge.” During an interview on 8/5/25 at 11:53 a.m. with the CNO, the CNO stated she is concerned about the inaccurate information the nurses placed in the medical record of Pt 4 and Pt 5. The CNO stated she expects nurses and doctors to go to the original source (the actual lab results) to determine if a patient is GBS positive. During an interview with Pt 4 on 7/31/25 at 2:28 p.m., Pt 4 stated, “My baby didn’t get sick until 2 days before I took her to (Named Childrens Acute Hospital-Hospital 2). Other kids in the house were sick, so I didn’t think much of it when the baby started acting different. She was 3 weeks old and seemed healthy. At first, she seemed to be overeating - 2 or 3 oz every few hours, she seemed really hungry, so when she first threw up I thought it was because she was overeating. She kept throwing up. She was acting colicky (colic is a condition that causes a baby to be irritable and to cry for a long time for no obvious reason. It is most common during the first 6 weeks of life.) Early Thursday morning I realized she hadn’t woken up to eat, so I woke her to feed her because it had been over 3 hours since she ate. She was breathing funny, grunting, and something was wrong. I called 911. The ambulance people gave her oxygen and said her oxygen was improving. They took her to (Hospital 2), and she was immediately put on a ventilator, then transferred to NICU (neonatal intensive care unit) and lines put in her groin (IV tubing to provide medications and fluids and monitor vital signs). They wanted to test her for meningitis, but they said she wasn’t stable enough. They asked me if I had GBS - I didn’t know what that was, they had to explain it. I said I didn’t think so, I told them “no”. My baby coded several times. They tried everything. Finally, they told me they couldn’t do anything more, and we took her off life support and she died. I talked to my clinic, and they said I was tested for GBS on 5/5/25, and the test came back positive (she had GBS.) I made a grievance report to the hospital after my baby died. They called me two weeks later. Pt 4 stated that if she had known what GBS was, and what meningitis was, she would have recognized the early signs of meningitis, including vomiting, and would have taken her baby to the emergency room two days earlier when she first started to get sick. For comparison, during a concurrent interview and review on 7/31/25 at 11:40 a.m. with the ADOB, the ADOB opened the EMRs for Pt 12 and Pt. 13. The EMR indicated Pt 12 was an infant born on 6/22/25 at 39 weeks gestation to a mother (Pt 12) who tested positive for GBS. Pt 12’s EMR indicated she was admitted to the hospital on 6/21/25 at 7:45 a.m. and was given ampicillin (an antibiotic used to treat GBS) at 10:39 a.m., and again at 2:15 p.m., 6:02 p.m., and 9:46 p.m. Pt 13 was born on 6/22/25 at 3:36 a.m. and mother and baby were sent home on 6/23/25 at 1:35 p.m. The hospital document for Pt 13 titled, “Discharge Summary” by MD 10 dated 6/23/25 at 9:32 a.m. indicated, “ ... Diagnosis: ... Newborn affected by (positive) maternal group b Streptococcus (GBS) colonization ... Discharge Instructions: Call office or go to the nearest emergency room if baby has fever greater than 100.4 F, irritability, refusal to feed, increasing jaundice or shows signs of dehydration.” During a review of documents from Hospital 2, the document titled, “ED Provider notes dated 5/29/25 at 2:18 a.m. indicated, “Patient Identification: [name of Pt 5] Chief Complaint: Breathing problem and fever - High Risk ... Mother provided history. History of Present Illness: ... 22-day-old female who presents with vomiting and difficulty breathing. She is accompanied by her mother ...Past Medical History: Child born: ... GBS negative. During a review of documents from Hospital 2, the document titled, “Meningitis/Encephalitis Panel by PCR dated 5/30/25 indicated it was collected on 5/30/25 at 9:24 p.m. The specimen was cerebral spinal fluid that was collected from Pt 5. The laboratory result showed that Pt 5 had GBS. Pt 5 died at Hospital B on 5/29/25. During a review of the hospital document titled, “Care Plan” dated 5/8/25 at 10:58 a.m., the document did not include risk of infection and did not include knowledge deficit (lack of understanding) regarding GBS or signs and symptoms of GBS. During a concurrent interview and document review on 7/30/25 at 11:13 a.m. with the Patient Safety Officer (PSO) and the Risk Manager (RM 1), the PSO stated the hospital became aware of the death of Pt 5 on 6/26/25 when the baby’s mother (Pt 4) filed a Grievance Report (a formal complaint) about the lack of care she received, which she believed resulted in the death of her baby. The PSO stated the hospital’s internal investigation processes are called a CERT (Critical Event Review Team) and an RCA. The PSO stated the CERT review occurred on 6/27/25 at 9:00 a.m. and was attended by members of the hospital’s executive leadership team, including the President and Market Leader (PML) and the Chief Nursing officer (CNO), and others. The RCA (part 1) was conducted on 7/2/25 at 10:30 a.m. and included the Chief Medical Officer, CNO, and others. The RCA (part 2) was attended by nurse leaders from the Women and Infants Department. The PSO stated that after the RCA was completed, the executive leaders determined that the incident did not meet criteria to be reported to CDPH. During an interview on 8/1/25 at 11:30 a.m. with the President and Market Leader (PML) the PML defended the hospitals decision to not report the incident to CDPH, stating the infant died of “late onset meningitis” so the care provided at the hospital did not lead to the infant’s death. The PML stated they only report what they absolutely need to report, and that it was an executive decision not to report. During a review of California Code of Regulations, Title 22 Social Security, Division 5. Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies, Chapter 9. Psychiatric Health Facilities Article 4. Administration, dated August 6, 2014, 77139. Health Record Service indicated, “(a) Unusual occurrences shall be reported by the facility, within 24 hours, either by telephone with written confirmation, or by telegraph to the county mental health director and the Department. (b) An unusual occurrence report shall be retained on file by the facility for three years. (c) The facility shall furnish other pertinent information related to such occurrences as the county mental health director or the Department may require. d) A facility admitting a patient exhibiting a physical injury or presenting a condition caused by neglect shall immediately notify a physician and request a physical examination of the patient. If, in the opinion of the examining physician, the injury or condition appears to be the result of neglect or abuse, the facility shall report such fact by telephone, and in writing, within 24 hours of the patient’s admission, to the Department, the local police authority having jurisdiction, and the county mental health department. Written reports in the patient’s health record shall state the character and extent of the physical injury or condition. (e) Every fire or explosion which occurs in or on the premises shall be reported immediately to the local fire authority, or in areas not having an organized fire service to the State Fire Marshal.” During a review of Health and Safety Code section 1279.1, date unknown, the code indicated, “ (a)A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law. (b)For purposes of this section, “adverse event” includes any of the following:... (D)The death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a facility. (7)An adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor. (c)The facility shall inform the patient or the party responsible for the patient of the adverse event by the time the report is made. (d)”Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual, or the loss of bodily function, if the impairment or loss lasts more than seven days or is still present at the time of discharge from an inpatient health care facility, or the loss of a body part. (e)Nothing in this section shall be interpreted to change or otherwise affect hospital reporting requirements regarding reportable diseases or unusual occurrences, as provided in Section 70737 of Title 22 of the California Code of Regulations. The department shall review Section 70737 of Title 22 of the California Code of Regulations requiring hospitals to report “unusual occurrences” and consider amending the section to enhance the clarity and specificity of this hospital reporting requirement.””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to identify one of five newborns at risk of serious infection when patient (Pt) 4, mother of Pt 5, was not identified or treated for Group B Streptococcus infection (GBS - a common bacteria that is usually harmless for adults, but can cause serious illness or death to newborns) and Pt 5 was discharged untreated and no education was given to mother of Pt 5 for signs and symptoms of infection. Nurses and the pediatrician were aware of the possible serious complications from GBS to Pt 5 and did not make sufficient effort to determine the status of Pt 4’s GBS laboratory results. These failures resulted in the mother of Pt 5 being discharged with lab results for GBS as “no results”, no follow up or education on the seriousness of a possible infection with GBS, and no education on newborn symptoms which led to the probable avoidable death of Pt 5, at 3 weeks of age. Findings: During an interview on 7/29/25 at 10:35 a.m. with Registered Nurse (RN) 3, RN 3 stated, “Patients are usually identified as GBS positive in the doctor’s office, and we get a report. If not, we have the option of asking the doctor for an order for a “rapid GBS” which gives results in about 60 minutes. The pregnant patient is treated with ampicillin (a medicine used to treat infections) every 4 hours if they are positive GBS. This reduces the risk for the baby.” During an interview on 7/29/25 at 10:45 a.m. with RN 4, RN 4 stated, “for GBS positive mothers, doctors usually treat with ampicillin 2 grams to start, then 1 gram every 4 hours until delivery. How they treat also depends on how long the mom has been ruptured (how long since her water broke). Once delivered, the nursery nurse cares for the baby. They do a sepsis (the body ’ s extreme response to a life-threating infection) workup on the baby.” During an interview on 7/29/25 at 10:55 a.m. with RN 5, RN 5 stated she works in the nursery caring for newborn babies. RN 5 stated, “ ... if mom (mother of baby) is GBS positive, we make sure mom got treated (with antibiotics for GBS). If not, the doctor will order a sepsis workup for the baby (tests to check for GBS infection). If the baby has a temperature, we call the doctor immediately.” During an interview on 7/29/25 at 11:10 a.m. with RN 6, RN 6 stated she is a postpartum nurse (a nurse who takes care of the mother and baby after the baby is delivered.) RN 6 stated, “if mom is GBS positive, we monitor the baby for signs of infection. We find out if mom was treated for greater than 4 hours with antibiotics. Most pediatricians keep the baby for 48 hours for monitoring if the mother was GBS positive.” During an interview on 7/29/25 at 11:20 a.m. with RN 7, RN 7 stated she was a postpartum nurse. RN7 stated the nurses in Labor and Delivery tell the nurses in postpartum if the mother was GBS positive. The nursery nurse tells the pediatrician. They check the prenatal record to see if the mother was positive and to see if she has been treated with antibiotics. We usually observe the baby for 48 hours if the mom is GBS positive. During a concurrent interview and record review on 7/30/25 at 10:10 a.m. with the Assistant Director of Obstetrics (ADOB) and the Interim Manager (Mgr 5) of the Obstetrics Emergency Department (OBED), the ADOB opened the Electronic Medical Record (EMR) for Pt 4. The EMR indicated Pt 4 came into OBED on 5/7/25 at 12:51 a.m. and stayed in the OBED for 1 hour 18 minutes. At 1:29 a.m., the on-call Obstetrician (MD 4), called the OBED. Mgr 5 stated, “they were batching the phone calls.” Mgr 5 explained that “batching” means that all the nurses who need to talk to the on-call doctor tell one nurse what they need to ask the doctor about different patients, and one nurse relays all the information to the on-call doctor. The nurse (RN 8) who talked to MD 4 was not the RN assigned to Pt 4 and told MD 4 about Pt 4 ’ s condition and inaccurately told MD 4 that Pt 4 was GBS negative. Mgr 5 stated, “I don’t know where she got that information. She might have been confusing the patients. Nurses have been told not to batch calls, or at least not to report on other nurses ’ assignments.” During a concurrent interview and record review on 7/30/25 at 5:10 p.m. with MD 3, MD 3 stated he is the pediatrician who discharged Pt 5. MD 3 stated he relies on the nursing documentation to determine if the mother of the baby is GBS positive, and the nursing notes indicated Pt 4 was GBS negative in the “Neonatal Sepsis Risk” (a scoring tool that determines how likely the newborn baby is to get a serious infection) note. MD 3 stated he does not look for a lab result to determine if the mother was GBS positive. MD 3 stated he was aware that there is a “rapid strep” test that can be done to determine if a mother is GBS positive if they do not know the status. MD 3 stated the test is called a PCR (Polymerase Chain Reaction - a testing method that yields results very quickly). During a concurrent interview and record review on 7/30/25 at 5:25 p.m. with the ADOB, the “Neonatal Sepsis Risk” for Pt 5 was reviewed. The “Neonatal Spsis Risk” indicated “Values Information ...taken by [RN 9] on 5/7/25 at 12:00, Recorded by [RN 9] on 5/7/25 at 12:18. “Maternal Group B Strep Status” indicated “2” which indicated Pt 4 was “negative” for GBS. The ADOB stated this information was entered by the nurse, and it isn ’ t a lab result. The ADOB stated, “I don ’ t know where she (RN 9) got that from. It ’ s a field that they (nurses) enter manually, it doesn ’ t flow over from another area in the chart.” During a review of hospital document titled, “History and Physical” dated 5/8/25 at 7:33 a.m. by MD 3, the note indicated, “ ... Prenatal Labs: No results found for: ... GBS, GBSCX (GBS culture)”. During a review of hospital document titled, “Discharge Summary” dated 5/8/25 at 7:33 a.m. by MD 3, the note indicated, “ ... Prenatal Labs: No results found for: ... GBS, GBSCX ...”. During a concurrent interview and record review on 7/31/25 at 2:00 p.m. with RN 10, RN 10 reviewed her notes for Pt 5 in the EMR. RN 10 stated she works in postpartum where they are assigned “couplet care” which means they take care of both the mother and the baby. RN 10 stated she was the nurse assigned to Pt 4 and Pt 5 on the day the mother and baby were sent home from the hospital. RN 10 reviewed her note titled, “Chat Conversations about [Pt 4]” which indicated, “Sender: [RN 10] ’ hey, this couplet should be good to go ...” informing the discharge nurse that the mother and baby were ready to be discharged home. RN 10 stated, “I have a checklist that I use to make sure the mother and baby are ready to go.” RN 10 stated that she saw MD 3 ’ s note that indicated there were no results for Pt 4 ’ s GBS status, which told her that MD 3 was aware of this and was discharging anyway. RN 10 stated, “Not having the results back doesn ’ t necessarily stop the discharge. The doctor might plan to follow up with the mother and baby after discharge.” During a review of the hospital document titled, “Care Plan” dated 5/8/25 at 10:58 a.m., the document did not include risk of infection and did not include knowledge deficit (lack of understanding) regarding GBS or signs and symptoms of GBS. During an interview on 8/5/25 at 11:53 a.m. with the Chief Nursing Officer (CNO), the CNO stated she is concerned about the inaccurate information the nurses placed in the medical record of Pt 4 and Pt 5. The CNO stated she expects nurses and doctors to go to the original source (the actual lab results) to determine if a patient is GBS positive. During an interview with Pt 4 on 7/31/25 at 2:28 p.m., Pt 4 stated, “My baby didn’t get sick until 2 days before I took her to (Named Childrens Acute Care Hospital- Hospital 2).Other kids in the house were sick, so I didn’t think much of it when the baby started acting different. She was 3 weeks old and seemed healthy. At first, she seemed to be overeating - 2 or 3 oz every few hours, she seemed really hungry, so when she first threw up I thought it was because she was overeating. She kept throwing up. She was acting colicky (colic is a condition that causes a baby to be irritable and to cry for a long time for no obvious reason. It is most common during the first 6 weeks of life.) Early Thursday morning I realized she hadn’t woken up to eat, so I woke her to feed her because it had been over 3 hours since she ate. She was breathing funny, grunting, and something was wrong. I called 911. The ambulance people gave her oxygen and said her oxygen was improving. They took her to (Hospital 2), and she was immediately put on a ventilator, then transferred to NICU (neonatal intensive care unit) and lines put in her groin (IV tubing to provide medications and fluids and monitor vital signs). They wanted to test her for meningitis, but they said she wasn’t stable enough. They asked me if I had GBS - I didn’t know what that was, they had to explain it. I said I didn’t think so. My baby coded several times. They tried everything. Finally, they told me they couldn’t do anything more, and we took her off life support and she died. I talked to my clinic, and they said I was tested for GBS on 5/5/25, and the test came back positive (she had GBS). I made a grievance report to the hospital after my baby died. They called me two weeks later.” Pt 4 stated that if she had known what GBS was, and what meningitis was, she would have recognized the early signs of meningitis, including vomiting, and would have taken her baby to the emergency room two days earlier when she first started to get sick. During a concurrent interview and review on 7/31/25 at 11:40 a.m. with the ADOB, the EMRs for Pt 12 and Pt. 13 was reviewed for comparison. The EMR indicated Pt 12 was an infant born on 6/22/25 at 39 weeks gestation to a mother (Pt 12) who tested positive for GBS. Pt 12 ’ s EMR indicated she was admitted to the hospital on 6/21/25 at 7:45 a.m. and was given ampicillin (an antibiotic used to treat GBS) at 10:39 a.m., and again at 2:15 p.m., 6:02 p.m., and 9:46 p.m. Pt 13 was born on 6/22/25 at 3:36 a.m. and mother and baby were sent home on 6/23/25 at 1:35 p.m. The hospital document for Pt 13 titled, “Discharge Summary” by MD 10 dated 6/23/25 at 9:32 a.m. indicated, “ ... Diagnosis: ... Newborn affected by (positive) maternal group b Streptococcus (GBS) colonization ... Discharge Instructions: Call office or go to the nearest emergency room if baby has fever greater than 100.4 F, irritability, refusal to feed, increasing jaundice or shows signs of dehydration” During a review of documents from Hospital 2, the document titled, “ED Provider notes dated 5/29/25 at 2:18 a.m. indicated, “Patient Identification: [name of Pt 5] Chief Complaint: Breathing problem and fever - High Risk ... Mother provided history. History of Present Illness: ... 22-day-old female who presents with vomiting and difficulty breathing. She is accompanied by her mother ...Past Medical History: Child born: ... GBS negative. During a review of documents from Hospital 2, the document titled, “Meningitis/Encephalitis Panel by PCR dated 5/30/25 indicated it was collected on 5/30/25 at 9:24 p.m. The specimen was cerebral spinal fluid that was collected from Pt 5. The laboratory result showed that Pt 5 had GBS. Pt 5 died at Hospital B. on 5/29/25. During a review of the facility’s policy and procedure (P&P) titled, “Women and Infant Services” dated 08/22, indicated “...To provide guidelines to the staff when discharging the newborn...Newborns are discharged in a safe and consistent manner...The newborn will meet the established discharge criteria prior to discharge. Discharge criteria includes....E. Any lab work within normal limits...Patient/Family Education 1. Parents instructed in areas of identified need. This includes but is not limited to...I. Temperature...M. Newborn Screen and Lab Draws...””

“ELIGIBILITY & PROCESS FOR APPT TO MED STAFF CFR(s): 482.22(a) The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope of practice laws, the medical staff may also include other categories of physicians (as listed at §482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to ensure eight of eight Allied Health Professionals (AHP), Perfusionists (A highly trained medical professional who operates the heart-lung machine and other specialized equipment during cardiac surgery, ensuring the patient’s circulatory and respiratory functions are maintained while a surgeon operated on the heart.)1, 2, 3, 4, 5, 6, 7, and 8, were credentialed and privileged in accordance with the Medical Staff Bylaws, the Allied Health Professional (AHP) Manual, and California state law. Perfusionists 1, 2, and 3 were hospital employees and their hiring followed the hospital ‘s human resources process, not the medical staff process, they were not identified by the hospital as AHPs, their qualifications were not reviewed by the appropriate medical staff committees, and their duties were defined in a job description which did not include the requirement for physician orders and physician oversight (a requirement under Business and Professions Code [BPC] section 2590), or periodic evaluation. Perfusionists 4, 5, 6, 7, and 8 were not hospital employees, were not identified by the hospital as AHPs, their qualifications were not reviewed and validated by the medical staff office, the appropriate medical staff committees, or the hospital ’ s human resources department, and neither a credential file or human resources file was maintained for Perfusionists 4, 5, 6, 7, and 8. The qualifications specified in the contract did not include current American Heart Association (AHA) Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) certification as was required of the perfusionists employed by the hospital. Their duties were specified in the contract to be performed under the supervision of either the primary surgeon or treating physician, however there was no process in place for periodic evaluation of the perfusionist ’ s performance by a physician, or the Chief Perfusionist, and the perfusionists were not subjected to proctoring. These failures resulted in the potential harm of permitting perfusionist to perform their duties in the operating room without the benefit of ensuring they were qualified and possibly negatively affecting patient care. Findings: During an interview on 7/30/25 at 11:55 a.m. with the Director of Medical Staff Services (DMSS), the DMSS stated the perfusionists were not credentialed and privileged following the process for Allied Health Professionals (AHP), as specified in the Medical Staff Bylaws and the AHP manual. The DMSS stated she did not know the rationale for that decision; when she started working at the hospital a few years ago she was told it was because perfusion was a contracted service. The DMSS confirmed that the presence of a contract does not determine whether or not the credentialing and privileging process is followed. The credential file for an AHP (AHP 2) was reviewed. The process for evaluation of AHP 2’s application for AHP membership and privileges included verification of her education and training, licensing and board certification, experience, Advanced Cardiovascular Life Support (ACLS) and Basic Life Support (BLS), malpractice insurance, health status, peer references, query of the National Practitioner Data Bank (NPDB- an information clearinghouse related to the professional competence and conduct of physicians, dentists, and other health care practitioners), Office of Inspector General (OIG) and System for Award Management (SAM), both used in healthcare compliance to identify individuals and entities excluded from participating in federal healthcare programs. Once on staff, AHP 2 was monitored for completion of proctoring, and there was an evaluation by the supervising physician. During an interview on 7/31/25 at 4:30 p.m., with the Chief Perfusionist (CP), the CP stated he is one of three perfusionists who are employees of the hospital. The CP stated one of the three perfusionists is on leave at this time. The CP stated the hospital has a contract with a perfusion group with five perfusionists who are not hospital employees, and he (the CP) coordinated the schedule with the lead person in that group in order to cover the surgery needs as well as the on-call coverage needs. The CP stated he does not keep any personnel files or any information regarding the five contracted perfusionists, does not have input into their contract, and does not complete or have input into an evaluation of their performance, and does not ensure annual competencies are completed. The CP stated he completed the evaluations of the other two perfusionists who are employees of the hospital, with the nursing director’s approval. The CP stated the perfusionists are not evaluated by the cardiac surgeons or any other physician members of the surgical team. The CP stated the physician’s input is not requested. As far as competency assessment for the perfusionists, the CP stated the employed perfusionists complete annual competencies and he signs them off. The annual competencies specific to the two other employed perfusionists were requested. The CP stated he did sign them off but was unable to find the documentation of those completed competencies. The CP stated he is unsure why the hospital does not credential and privilege the perfusionists, and stated “we are allied health” [professionals]. During a review of the hospital document titled, “Bylaws of the Medical Staff,” dated 7/27/18, the document indicated, “SPECIAL CONDITIONS APPLICABLE TO ALLIED HEALTH PROFESSIONALS. Allied Health Professional or AHP means an individual, other than a licensed physician, dentist, or podiatrist, who exercises independent judgment within the areas of his or her professional competence and the limits established by the Board of Trustees, the Medical Staff, The Interdisciplinary Practices Committee, and the applicable State Practice Act, who is qualified to render direct or indirect medical, dental, or podiatric care under the supervision or the direction of a Medical Staff member possessing privileges to provide such care in the Hospital, and who may be eligible to exercise privileges and prerogatives in conformity with the rules adopted by the Board of Trustees, the Allied Health Professional Policy Procedure Manual, and these Bylaws ... GENERAL POLICIES APPLICABLE TO ALLIED HEALTH PROFESSIONALS. No person shall be entitled to perform services solely because he or she holds a certain degree, is licensed to practice in this or any other state, is a member of any professional organization, is certified by any clinical board, or because such person had, or presently has, been able to perform services at another healthcare facility ... Each category of AHP shall have a qualifications statement and task list approved by the Interdisciplinary Practices Committee (“IPC”). Additionally, professionals who are required by law to provide a scope of practice shall be responsible for providing same to the IPC. The AHP shall sign an agreement to abide by the Hospital and Medical Staff Policies/Procedures and the Bylaws of the Medical Staff.... INITIAL APPOINTMENTS OF ALLIED HEALTH PROFESSIONALS SHALL BE PROVISIONAL. All initial appointments to the Allied Health Professional staff shall be provisional. The provisional AHP appointment shall last a minimum of 6 months. Monitoring of provisional AHP members shall include peer review, proctoring by nursing service as indicated by task list, and evaluation by the AHPs supervising physician. All members of the AHP staff are subject to the Hospital and Medical Staff ’ s performance improvement program and are required to participate in peer review or performance improvement activities ...” During a review of the hospital’s “Allied Health Professional Manual,” dated 5/16/25, the manual indicated, “FOCUSED PROFESSIONAL PRACTICE EVALUATION. Allied Health Professionals shall undergo focused professional practice evaluation at the time of initial appointment. 1. During the six-month provisional period, Allied Health Professionals will be required to have six cases reviewed by their supervising physician, a peer, or members of the Interdisciplinary Practices Committee. 2. Each review shall be documented on an AHP Case Review or Surgical Assistant evaluation form and submitted to the Interdisciplinary Practices Committee ...” DUTIES OF THE ALLIED HEALTH PROFESSIONAL. Upon appointment, each AHP shall be expected to: 1. Consistent with the approved privileges granted to her/him, exercise independent judgment within his or her areas of competence and, if applicable, within the limits of an approved Standardized Procedure, provided that a Medical Staff member who has appropriate privileges shall retain the ultimate responsibility for each patient ’ s care ...” During a review of the California Business and Professions Code (BPC)- Perfusionists Section 2590 (2024), the BPC indicated, “ ...2590 (a) For purposes of this section, “perfusion” means those functions necessary for the support, treatment, measurement, or supplementation of the cardiovascular system, circulatory system with or without the oxygenation circuit, or any combination of those activities, and to ensure the safe management of physiologic functions by monitoring the necessary parameters of those systems pursuant to an order and under the supervision of a licensed physician and surgeon ...(e) Except as provided in subdivision (f), persons holding themselves out as perfusionists shall be graduates of a training program described in Section 2592 and produce satisfactory evidence of successful completion of the entire examination of the American Board of Cardiovascular Perfusion ...” During a review of the hospital document titled, “Perfusionist Position Description,” dated 3/15/23, the document indicated, “ ...Reporting to the Chief Perfusionist, Cardiothoracic Surgical Serv., this position is responsible for operating extracorporeal circulation equipment during surgery to maintain the patient’s normal physiologic condition. REQUIREMENTS: 1. Successful completion of an accredited perfusion training program is required. 2. National Certification (Certified Clinical Perfusionist (CCP)) through the American Board of Cardiovascular Perfusion is required. 3. Current American Heart Association (AHA) Healthcare Provider CPR card is required. 4. Current American Heart Association (AHA) Advanced Cardiac Life Support (ACLS) Provider card is required. 5. Ability to create the necessary bypass circuit to support a patient with any number of abnormalities and successfully manage each situation is required. 6. Must be knowledgeable concerning the variety of equipment available and techniques to be used ... ROLE SPECIFIC ACCOUNTABILITIES: ... 1. Administer the necessary support, treatment, measurement, or supplementation of the cardiopulmonary and circulatory system of the surgery patient. Operate extracorporeal circulation equipment during any medical situation where it is necessary to support or replace the patient ’ s cardiopulmonary/circulatory function and ensure the proper management of physiologic functions by monitoring the necessary variables ...” The job description did not include the requirement that a perfusionist ’ s duties were to be performed in accordance with an order and under the supervision of a licensed physician and surgeon. During a review of the contract between the hospital and the perfusionist group titled, “Perfusionist Services Agreement,” dated 7/10/25, the document indicated, “DUTIES AND RESPONSIBILITIES OF PROVIDER: Perfusion Services. Provider will use its best efforts to obtain, and make available to the Hospital, Perfusionists who are acceptable to the Hospital and who will upon request and under the supervision of either the primary surgeon or treating physician, perform the following services during the period of time agreed to by the Hospital and Provider: Operate a heart/lung machine and other ancillary support equipment. Administer blood, blood products, anesthetics and drugs through the extra-corporeal circuit, Perform initial set-up and timing of an intra-aortic balloon pump. Operate a blood salvage system during cardiac and non-cardiac surgeries. Remain on the hospital premises for follow-up care if so instructed by the primary surgeon or treating physician. Other duties in accordance with the American Society of Extracorporeal Technology ’ s Perfusionist Scope of Practice ... Qualifications. All Perfusionists provided to the Hospital by Provider will be certified as a Certified Clinical Perfusionist (“CCP”) by the American Board of Cardiovascular Perfusion ... DUTIES AND RESPONSIBILITIES OF HOSPITAL. Appropriate orientation of Provider ’ s clinical staff to Hospital; including program-specific policies, procedures and equipment. Timely credentialing of Perfusionist (including requisition of physician sponsorship letters) as may be required to meet the commencement date set forth in Paragraph 2 above ...Assignment of the Perfusionist to areas of practice within their clinical competency ...” During a review of the hospital document titled, “Position Description: Chief Perfusionist,” dated 3/15/23, the document indicated, “Summary: Reporting to the Director, Surgical Services, Nursing Service Admin, this position is also under the clinical direction of the Medical Director for Cardiovascular Services and is accountable for the application and delivery of cardiovascular perfusion services throughout [name of hospital]. This includes cardiopulmonary bypass, cell savers, and intra-aortic balloon pump in the operating rooms [ORs], the supervision of Extracorporeal Life Support (ECLS) technologies in the ORs/CICU, and the use of these technologies for any transport as well as the operation of cell saver equipment in all surgical areas. This position is responsible for the coordination of the activities of the perfusion department by providing the supervision of perfusion services, personnel and equipment, providing oversight of the staffing and call schedules, and coordination of all perfusion department resources to ensure compliance with perfusion policies, procedures and professional standards.” During a review of the document titled, “American Board of Cardiovascular Perfusion (ABCP) Certification Job Description Resource for the Certified Clinical Perfusionist (CCP) Credential,” dated 9/24, the document indicated, “ ...Perfusionist Definition: A “Perfusionist” is a person, qualified by academic and clinical education, to operate the extracorporeal circulation equipment during any medical situation where it is necessary to support or replace a person’s cardiopulmonary, circulatory, or respiratory function. A perfusionist is responsible for the selection of appropriate equipment and techniques necessary for support, treatment, measurement, or supplementation of the cardiopulmonary and circulatory system of a patient, including the safe monitoring, analysis, and treatment of physiologic conditions under an order and under the supervision of a physician. A CCP validates his/her mastery of these clinical skills, knowledge, and abilities through certification and meets ongoing continuing education and practice requirements through recertification ...” During a review of the document titled, “Medical Board Staff Report- Healthcare Practitioner Supervision Requirements,” dated 1/12/13, the document indicated, “A Perfusionist is a trained Allied Health Professional responsible for the heart-lung machines necessary for cardiovascular surgeries. This individual must be supervised by a licensed physician and surgeon in accordance with Section 2590 (a) of the Business and Professions Code. Since January 1, 1993, no person shall hold himself or herself out as a perfusionist, unless 1) he/she is a graduate of a training program reviewed by the Accreditation Committee on Perfusion Education and approved by the Commission on Accreditation of Allied Health Education Programs or its successor and 2) he/she has successfully completed the entire examination of the American Board of Cardiovascular Perfusion ...” During a review of the Journal of Thoracic Cardiovascular Surgery article titled, “Cardiovascular perfusion: Evolution to Allied Health Profession and Status 1986,” dated 10/86, the article indicated, “ ...The occupation of cardiovascular perfusion has evolved from a technical to a professional status during the past 25 years. The national thoracic surgical organizations, The American Association for Thoracic Surgery and the Society of Thoracic Surgeons, have supported this process of development through participation on various boards and committees of the perfusionist organizations. The rapid growth of cardiac surgical services in the past decade produced concern about the availability of perfusionist manpower ...Today, manpower concerns have been resolved, and cardiovascular perfusion is a recognized Allied Health Profession responsive to the needs of patients, cardiac surgeons, and the general public ...” During a review of the “American Society of Extra Corporeal Technology Standards and Guidelines for Perfusion Practice,” dated 5/17, the guidelines indicated, “ ... Perfusionists are the only allied healthcare professionals formally trained and educated in the field of extracorporeal science and whose scope of practice expressly includes the utilization of extracorporeal devices ...””

“MEDICAL STAFF PERIODIC APPRAISALS CFR(s): 482.22(a)(1) The medical staff must periodically conduct appraisals of its members. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to periodically appraise the professional performance of the medical staff members in accordance with the Medical Staff Rules, Regulations and policies, and to consider that appraisal when determining whether privileges will be granted, renewed, revised or revoked for 26 of 26 pediatricians (doctors who specialize in the care of infants, children and adolescents; MDs 3, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30) reappointed to the medical staff without first evaluating indicators of quality of care specific to pediatrics. These failures had the potential for privileges for patient care to be granted to physicians without demonstrated competence and placed patients at risk for harm. Findings: During an interview on 7/30/25 at 12:15 p.m. with the Director of Medical Staff Services (DMSS), the process for ongoing professional practice evaluation (OPPE- The routine ongoing monitoring and evaluation of current competency for practitioners with granted privileges) was discussed. The DMSS stated each medical staff department had specialty-specific indicators and data was collected for those indicators specific to each member of the medical staff. That information was put into a “report card” format which indicated the physician’s performance as compared to the established benchmarks (something that serves as a standard by which others may be measured or judged) or goals and to the physician’s peers. The DMSS stated those report cards were produced every eight months for the department chairman to review, and there was a summary report at the end of the two-year reappointment period, which was reviewed during the reappointment process. The DMSS stated if the physician had any specific cases reviewed by the peer review committee, the outcome of the review would be reflected on that report as well. During a concurrent interview and record review on 7/31/25 at 10:10 a.m., with the DMSS, the credential file of a pediatrician (MD 3) indicated MD 3 was reappointed on 10/1/24 for a two year reappointment period. Review of MD 3’s OPPE reports indicated how MD 3 performed during the previous two year period specific to compliance with computer order entry, admission medication reconciliation (does not apply to newborn admissions), and days of suspension for incomplete medical records. The DMSS stated the review of medical records is done by the health information management (HIM) department, however HIM ‘s role does not involve evaluation of the quality or content of the documentation or the completeness of the assessments. The DMSS stated data for these indicators was collected for all medical staff members regardless of their specialty. MD 3 ‘s report indicated there were no cases reviewed by the peer review committee. The other information collected and reported for MD 3 included the rate of patients who had cesarean section deliveries compared to total deliveries, the rate of patients who delivered vaginally after having a previous cesarean section (VBAC), the rate of elective deliveries before 39 weeks gestation, birth injuries, maternal complications during delivery, rate of episiotomies, and maternal readmissions within 15 days and 30 days. The report indicated MD 3 ’ s data for each indicator was “No Data.” The DMSS confirmed these indicators do not apply to the practice of a pediatrician, and stated the pediatricians and the obstetricians (physicians who specialize in the care of women during pregnancy, labor, and childbirth) are grouped together in one department (OB/Gyn/Peds), so the report card reflected indicators that apply to the obstetricians. The DMSS stated that in the future there will be a department of pediatrics and neonatology (a subspecialty of pediatrics, focused on the care of newborns, particularly those who are premature or have critical illnesses), so then OB indicators won’t be included in the OPPE report cards for the pediatricians. Review of the documents titled “OPPE indicators” and “Peer Review Indicators 2025” indicated for pediatrics an indicator was “Discharge of infant at 36 hours or less with a bilirubin level in the high-risk zone,” however the DMSS stated currently data was not being collected for that indicator. The DMSS stated the current OPPE report for the OB/Gyn/Peds department physicians does not reflect an evaluation of data specific to the performance or practice of a pediatrician. During a concurrent interview and record review on 7/31/25 at 11 a.m. with the DMSS, the credential file of the pediatric division chair (MD 6) indicated MD 6 was reappointed on 8/1/25 for a two year reappointment period. Review of the OPPE report indicated data reported for HIM suspension days, computer order entry compliance and medication reconciliation (not applicable to newborn admissions). The report included the indicators which applied to the obstetricians and indicated “No Data” for MD 6. MD 6 ‘s report indicated there were no cases reviewed by the peer review committee. The DMSS stated all of the pediatricians had the same report card in terms of what data was collected. During a review of the document titled “Updated Medical Staff Roster to Include Allied Health Professionals [AHP],” dated 7/29/25, the document indicated there were a total of 29 pediatricians on staff, and 26 of those pediatricians had been reappointed to the medical staff at least once. During a review of the hospital ‘s Medical Staff Policy and Procedure (P&P) titled, “Peer Review [MS 123],” dated 4/9/19, the P&P indicated, “Purpose: To ensure that the hospital/healthcare organization, through the activities of its Medical Staff, assesses through an Ongoing Professional Practice Evaluation its individuals granted clinical privileges. This process shall utilize a centralized multi-specialty, data based evaluation of the practitioner’s performance. The Medical Staff Quality Committee shall be granted the authority to perform such Peer Review. Goals: Monitor and evaluate the ongoing professional practice of individual practitioners with clinical privileges. Assure that the process for peer review is clearly defined, fair, defensible, timely and useful. Provide accurate and timely performance data for practitioner feedback, Ongoing and Focused Professional Practice Evaluation, and reappointment. Procedure: The detailed description of peer review, Ongoing Professional Practice Evaluation, Validation of Perception based Rule Indicator Occurrences, and methodology of conducting the business of the Medical Staff Quality Committee shall be delineated in the Peer Review Manual, which will be kept up to date and reviewed every two years or sooner if needed.” During a review of the hospital ‘s “Peer Review Manual [PRM],” dated 5/23, the PRM indicated, “ ... The Medical Staff Peer Review Committee [MSPRC] will be responsible for measuring and evaluating all areas of practitioner competency for care at [name of hospital] ...Peer review: The evaluation of an individual practitioner ’ s professional performance for all relevant competency categories using multiple sources of data and the identification of opportunities to improve care .... Goals of Peer Review: Monitor and evaluate the ongoing professional practice of individual practitioners with clinical privileges; Provide accurate and timely performance data for practitioner feedback, Ongoing and Focused Professional Practice Evaluation, and reappointment. Ongoing Professional Practice Evaluation (OPPE): The routine monitoring and evaluation of current competency for practitioners with granted privileges. This is accomplished through the peer review process. The Medical Staff will use the provider-specific peer review results in making its recommendations to the hospital regarding the credentialing and privileging process and, as appropriate, in its performance improvement activities. Performance Measurement and OPPE/FPPE a. Selection of Practitioner Performance Measures: Practitioner performance measures will be selected that will address the six General Competencies, are appropriate to the practitioner ’ s specialty, are reflective of practitioner performance, and are attributable to individual practitioners or defined groups of practitioners. These measures will utilize multiple sources of data described in the Medical Staff Indicator List. Whenever appropriate, the indicators should be linked to specific privileges or privilege groups. The MSPRC will have the authority to develop and implement specialty-specific indicators if not provided by the departments in a reasonable timeframe ... Reappointment: At time of reappointment, the Department Chair will review the past two years of OPPE and FPPE data and document the interpretation and any improvement activities for each indicator that shows Needs Follow-up. The Department Chairs will also be provided an interim report of rule and case review results ... [The MSPRC] in coordination with the Credentials Committee, define the appropriate content and format for practitioner performance feedback reports and reappointment profiles as approved by the Medical Executive Committee ...” During a review of the “Rules and Regulations of the Medical Staff [R&R],” dated 7/28/17, the R&R indicated, “The Medical Staff Quality Committee [MSQC] shall be responsible for measuring and evaluating all areas of practitioner competency for care provided at [name of hospital], define practitioner performance indicators and targets for the General Competencies in collaboration with the appropriate departments and specialties as approved by the MEC, evaluate practitioner performance for these indicators to determine if improvement opportunities exist either through case review or using aggregate data for patterns and trends, assure accountability by the Medical Staff departments for the development of improvement plans when appropriate, oversee any other Medical Staff specialty specific peer review activities. Interim Medical Staff Evaluations: In order to fulfill The Joint Commission standard concerning medical care evaluation, performance improvement and patient safety activities, the MSQC, in conjunction with Hospital Administration and other committees of the Medical Staff, shall perform the following actions for each Practitioner’s Medical Staff appointment cycle: Perform ongoing professional practice evaluations (“OPPE”) of all Members of the Medical Staff and focused professional practice evaluations (“FPPE”) when concerns arise from OPPE based on the general competencies defined by the Medical Staff; Set expectations and define both individual and aggregate measures to assess current clinical competency of all Members of the Medical Staff, provide feedback to the Members of the Medical Staff and develop plans for improving the quality of clinical care provided in the Hospital; and actively be involved in the measurement, assessment, and improvement of activities of Practitioner performance ...” During a review of the article titled, “An OPPE system for ‘specialty-specific’ metrics,” dated 4/6/15, retrieved from Credentialing Resource Center Digest at https://credentialingresourcecenter.com/articles/oppe-system-specialty-specific-metrics, the article indicated,” ...Inclusion of practitioner performance metrics that are specific more to a particular specialty, department, service line, or privilege(s) that cross specialty lines allows greater specific scrutiny of competency within a defined clinical domain. The metric chosen will obviously only apply to some subset of practitioners, but the specificity allows better definition for driving improvement and quality care in an area or a procedure or a privilege that is relevant to that department/section/service line ...Indicator: Select an indicator that defines a clear measure of the expectation. “Specialty specific” indicators will be limited to a smaller subset of practitioners than the general indicators. Targets: Targets are metrics that are defined to look at trends and overall aggregate performance of physicians against the selected indicator ... Your medical staff will need to do the research and education to understand how to set targets that will be meaningful to improve physician performance in your organization. Feedback and evaluation is essential to drive the success and credibility of any OPPE system. Your organization determines who reviews this data and how often. The ultimate goal is to ensure competency and to make recommendations to maintain, modify, restrict, or revoke a privilege...” During a review of the article titled, “Credentialing and Privileging Provider Profiling,” dated 2/29/24, retrieved from https://www.ncbi.nlm.nih.gov/books/NBK603712/, the article indicated, “ ...Provider profiling involves systematically compiling and analyzing information related to the healthcare provider to define their characteristics in certain areas, including knowledge, professionalism, communication, procedural competency, and patient outcomes... Credentialing assesses if a provider meets institutional requirements for staff inclusion, such as training, board certification, and malpractice event history. In contrast, privileging evaluates a provider’s behavior, skills, and procedures within their practice scope at the institution ...Provider profiling continues throughout medical staff membership to demonstrate ongoing quality performance and ensure the provider’s medical and procedural quality and currency. Healthcare institutions and the medical staff use Ongoing Professional Practice Evaluation (OPPE) to monitor providers’ continuing performance and competency. Profiling of provider performance metrics is critical to the OPPE process and focuses mainly on outcome variances. The OPPE process is intended to help ensure the quality of care with continuous tracking, feedback, and action plans directed to areas where opportunities for improvement are identified. Reporting and evaluation intervals for OPPE reports should be more than once every 12 months, with cycle length determined by the institution. The OPPE data for each practitioner should be specific to their specialty, relevant, and valid. It should encompass critical metrics to facilitate ongoing quality improvement for the individual practitioner and the broader department and institution ...All practitioners must undergo reappointment to the medical staff ...The reappointment process involves a comprehensive assessment of the practitioner’s current performance profile with the institution and the medical staff. The OPPE report, in conjunction with a current query of the same databases accessed in initial credentialing, establishes the foundation element for review by the Credentials Committee and the Chair of the Department. The reappointment profiling report determines whether the provider will receive an unconditional membership reappointment to the medical staff versus a conditional reappointment or is not recommended for reappointment. Individual privileges are also evaluated similarly to decide on the continuation or revocation of each privilege. The recommendation by the Credentials Committee is forwarded to the MEC and then to the facility’s Board of Directors for final approval ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47205 Based on interview and record review, the nursing staff failed to provide quality care in accordance with hospital policies and procedures when: 1. Nursing staff failed to recognize and assess the early signs and symptoms of an acute stroke (a sudden loss of blood circulation to an area of the brain) for one of three sampled patients, Patient (Pt) 2, in accordance with professional practice standards. This failure resulted in delayed response and management of the change in Pt 2’s medical condition. 2. The facility nursing staff failed to complete and document a Rapid Response Team (RRT-a hospital steam d respond to patients with early signs of clinical deterioration) call in the Electronic Medical Record (EMR- a digital version of a patient’s paper chart, containing medical and treatment information) from the bedside nurses for one of three sampled patients, Pt 2, in accordance with hospital P&Ps titled “Rapid Response Team (RRT),” dated 4/2023, and “Rapid Response Team Standardized Procedure” dated 4/11/25. These failures resulted in Pt 2 ’ s identified change of condition to not be readily available to care providers to use in further assessments and possibly negatively affecting Pt 2 ’ s care. 3. Nursing staff failed to remove an armband from one patient prior to applying a long-arm splint in the Emergency Department (ED) in accordance with professional practice standards. This failure caused discomfort for Pt 3 and required another visit to an emergency department, and had the potential to cause a pressure injury from the armband, which could cause an infection, and could have cut off blood flow to Pt 3 ’ s hand causing loss of function of his hand. Findings: 1. During an interview, on 7/31/25 at 3:13 p.m., with complainant (CO), the CO stated on the morning of 6/29/25, she arrived at Pt 2 ‘s bedside. CO stated while speaking with a family member (FM) a group of doctors (4-5 doctors) came into Pt 2 ‘s room and told them Pt 2 was in a “code stroke,” and that they were waiting for results of the MRI (a test that creates clear images of structures inside your body). CO stated family was informed by the doctors that Pt 2 was not a candidate for administration of tenecteplase (a clot-busting medication-indicated for the treatment of acute ischemic [a shortage of oxygen and nutrients] stroke in adults) because Pt 2 was “outside the window” for administration. The CO stated Pt 2 was later seen by a Neurologist (a medical doctor who specializes in diagnosing and treating disorders of the nervous system, including the brain, spinal cord, and nerves). CO stated on 7/2/25 family reported to staff that they noticed Pt 2 had swelling to her neck, and they requested Pt 2 be transferred to the Intensive Care Unit (ICU) as they were very concerned about Pt 2 ’ s continued signs of decline. The CO stated after a second RRT on 7/2/25 additional CT scans were ordered, and Pt 2 was finally transferred to the ICU. CO stated Pt 2 was immediately intubated (a tube is inserted through the mouth or nose, into the windpipe) on arrival to the ICU. CO stated now doctors recommendations are for “comfort measures” care due to Pt 2 ‘s poor prognosis. The CO stated all concerns and family requests were made directly to nurses and doctors. During an observation on 7/31/25 at 4:00 p.m., in Pt 2 ‘s room, Pt 2 was lying in bed with her head slightly elevated. Pt 2 was alone, appeared well groomed, with a tracheostomy (an incision made in the neck to create an opening into the trachea windpipe- allowing for a tube to be inserted to aid breathing) in place and tube feedings (delivering liquid nutrition through a tube, bypassing the mouth) infusing. RN 14 stated Pt 2 had complete paralysis after the stroke and was “locked-in.” RN 14 explained locked-in as being completely and mentally intact and aware, but not being able to move or speak. RN 14 pointed to a sign on the wall, which she said was made by family, at the head of Pt 2 ’ s bed which indicated “...[Pt 2] ...a mother of 5, grandmother of 4... please include me in conversations...” and that Pt 2 could communicate by “blinking, once for “yes” twice for “no.” A brief interview with Pt 2 was conducted due to limitation in communicating. During a review of Pt 2 ‘s ED Provider Note, dated 6/28/25, the ED provider note indicated “...[3:57 p.m.] 56 (year-old)... past medical history of [diabetes], [high blood pressure] currently not taking any medications presents emergency department complaints of generalized weakness, headaches ongoing for the past several days. On exam patient ‘s weak appearing, in moderate distress, actively gagging/nauseous. Patient otherwise has no other neurologic deficit... [4:57 p.m.] Patient became bradycardic (a resting heart rate below 60 beats per minute)...rate 49...[4:59 p.m.] Call to on-call cardiology...[6:03 p.m.] patient had a drop in heart rate...39...atropine (medication used to treat a slow heart rate) provided with improvement of symptoms...Patient given hydralazine which also improved the patient ’ s blood pressure. Patient at this time continues to be markedly weak...[6:59 p.m.] ...requested admission. [7:14 p.m.] Patient complaint of worsening abdominal pain. [8:00 p.m.] Pt and family understand and agree to [treatment] plan....will admit...” During a review of Pt 2 ’ s “ED Timeline” dated 6/28/25, the ED Timeline indicated “...[3:15 p.m] Patient arrived in ED...arrival complaint high bp...[3:19 p.m.] Vital Signs...BP: 193/93...[3:25 p.m.] ...Pain Score: 6...Pain Location: Head...Pain Descriptors: Aching... 15:57 CT HEAD WO CONTRAST (a diagnostic imaging procedure that uses X-rays and computer technology to produce detailed images of the brain, skull, sinuses, and other cranial structures without the injection of a special dye)...[4:33 p.m.] Medication Given acetaminophen tablet 650 mg...prochlorperazine (medication to treat nausea) 10 mg injection... [4:52 p.m.] Vital Signs...Heart Rate: 47...BP: 146/108...[5:57 p.m.] Medication Given atropine...0.5 mg intravenous (IV-within a vein)...17:59 (5:59 p.m.) Pain Assessment...no/denies pain...[6:44 p.m.] CT Head wo Contrast Resulted...[7:14 p.m.]...Patient complaint of worsening abdominal (stomach) pain...[7:49 p.m.]...Medication Given fentanyl (stong pain medication) 50 mcg IV...[8:00 p.m.] ...admission team...will admit...[9:41 p.m.]...Patient admitted to 5 North...” During a concurrent interview and record review on 8/1/25 at 8:30 a.m., with the 5 North (a cardiac unit) Manager (Mgr) 4, and RN 12 , Pt 2 ‘s medical recorded was reviewed. RN 12 stated she admitted Pt 2 to 5 North on 6/28/25. RN 12 stated she completed a head-to-toe assessment (an evaluation of all the body’s systems) and though she would not necessarily be aware of Pt 2 ’ s baseline (normal) mental status, she would have conducted a basic neurological exam. RN 12 explained a basic neurological exam consisted of assessing the patient orientation (patients awareness of their surroundings, time and their own identity), by asking them why they are in hospital, do they know where they are, and questions about their functioning (such as ability to walk) to assess weakness. RN 12 stated “yes” she documented “WDL” as she did not recall having any concerns. RN 12 explained WDL means her assessed findings are within defined limits (within established the established normal range). RN 12 stated Pt 2 ‘s cardiac status, was more concerning to her and it was her focus more so than stroke-type symptoms. RN 12 stated she received nursing hand-off report from the ED nurse via phone and no mention of lethargy was reported in the hand off. RN 12 stated she gave report to the day shift nurse, in person. Mgr 4 stated it is her expectation that nurses perform a full physical assessment which includes the body systems from head to toe (i.e.: neurological, gastrointestinal, and skin) documenting any findings falling out of the defined normal limits to ensure an accurate representation of the patient ’ s condition is available to care providers. During a review of Pt 2 ‘s “Care Plan Note (CPN)” dated 6/29/25, entered and signed by RN 12 at 6:29 a.m., the CPN indicated “...Patient did well over night, slept well over night, son at the bedside. More color to face, still lethargic...” During an interview on 8/1/25 at 8:51 a.m., with RN 13, RN 13 stated he recalls during report that Pt 2 was lethargic, did not have any significant overnight events and was pending a procedure that morning (6/29/25). RN 13 stated when he went to Pt 2 ’ s room the transport team was already there preparing Pt 2 for transport to procedural area. RN 13 stated he briefly introduced self and advised her of the pending test. RN 13 stated Pt 2 nodded her head and said OK. RN 13 stated upon Pt 2 ‘s return to the floor, he attempted a full head to toe assessment and noted “odd responses”. RN 13 stated he and Pt 2 ‘s son felt Pt 2 was showing left-sided facial droop. RN 13 stated he began a Face, Arm, Speech, and Time (FACE- used to help identify and remember the key signs of a stroke) exam and called for his Practice Coordinator (PC) to come to Pt 2 ‘s bedside to get a second set of eyes on the patient. After the PC ‘s assessment, the Rapid Response Team (RRT)/Crisis Nurse was called for what staff felt were positive signs of stroke. RN 13 stated that any staff observing a change in status can call a RRT/crisis nurse. RN 13 explained House Supervisor (HS) 1 responded because the RRT/Crisis Nurse was on another unrelated event. RN 13 stated his PC paged Pt 2 ‘s doctor using the paging system within the hospital electronic medical record (EMR) application. RN 13 stated it was decided not to call a stroke alert by providers after providers assembled at Pt 2 ‘s bedside. The electronic medical record did not include an assessment for Pt 2 at the time the providers were at bedside. RN 13 stated a resident doctor was explaining to family that a MRI had already been ordered, completed and was pending results and there were no other diagnostic tests to recommend at that time. RN 13 stated he was not sure Pt 2 completely understood the medical plan, he observed her nodding her head, but it was not clear if she understood. During a concurrent interview and record review on 7/31/25 at 2:00 p.m., with the Stroke Program Coordinator (SPC- a healthcare professional, often a registered nurse, who manages and oversees the care of stroke patients within a hospital or healthcare system), Pt 2 ‘s EMR was reviewed. SPC stated Pt 2 ‘s primary nurse on 7/2/25 notified her of Pt 2 ‘s stroke event which prompted her review of Pt 2 ‘s admission. SPC explained her role is to collect patient stroke data to ensure the hospital ‘s stroke program functions and meets the program regulatory requirements. SPC stated during her review of Pt 2 ‘s record, she did not find an entry by a nurse or physician about the RRT called on 6/29/25. During a review of Pt 2 ‘s “Flowsheet Data (FSD)” dated 7/31/25, the FSD indicated Pt 2 ‘s initial National Institutes of Health (NIH) Stroke Scale (NIHSS- a standardized tool used to assess the severity of a stroke with a total NIHSS score range from 0no stroke) to 42 (severe stroke) used to guide treatment decisions, predict stroke outcome, and monitor the patient’s progress) score on 6/29/25 at 9:34 a.m. was 25, indicating “severe stroke.” During an interview on 8/1/25 at 1:30 p.m., with the admitting Hospitalist physician - (a doctor whose primary professional focus is the general medical care of hospitalized patients), the Hospitalist stated he did a face-to-face evaluation of Pt 2 in the ED on 6/28/25 at 8:47 p.m., as indicated on Pt 2 ‘s admission H&P. Hospitalist stated he found Pt 2 was not alert, describing her as very sleepy, not able to follow commands, and “obtunded (a state of reduced alertness and responsiveness, a level of consciousness less alert than normal but not as unresponsive as a stupor or coma).” Hospitalist stated he decided to order a MRI of the brain without contrast due to an initial suspicion for stroke due to Pt 2 ‘s elevated blood pressure and after considering results of the tests ordered by the ED provider. Hospitalist stated he admitted Pt 2 to observation status for further testing and monitoring. Hospitalist stated the ED MD shared they were not sure of the source of Pt 2 ‘s abdominal pain but did not mention stroke was on their differential list (a list of possible diseases or conditions that could be causing a patient’s symptoms) of diagnoses. Hospitalist stated he signed over care to the day shift team at 7:00 a.m. on 6/29/25 endorsing pending MRI results and his suspicion for stroke. During a review of Pt 2 ‘s medical record report titled “MR Brain [without] Contrast , dated 6/28/25, the medical record indicated”...HISTORY: Dizziness...IMPRESSION:... suggestive of acute to subacute ischemic changes (indicates findings on a brain scan, like a CT or MRI, that point towards a stroke or other condition where blood flow to the brain is reduced, potentially causing cell damage)...Signed by:...on 6/29/25 [1:23 p.m.]...Exam Information...Exam Begun: 6/28/25 [11:19 p.m.]...” During an interview on 8/1/25 at 3:00 p.m., with the Emergency Department Medical Doctor (EDMD), the EDMD stated he recalled Pt 2 “[she] didn ‘t look well; was very weak, laying in a wheelchair, and presented with an array of symptoms.” EDMD stated Pt 2 and family described symptoms (abdominal pain, headache) for the last 2 days. EDMD stated he was worried about the high blood pressure and her atypical presentation. EDMD admitted he did not really know what was going on and he expressed this to Pt 2 ‘s son. EDMD stated he suspected sepsis (sepsis is the body’s extreme response to an infection), he considered Pt 2 ‘s vital signs which seemed stable, her initial CT was negative, her symptoms were past 24 hours (the last known normal time which is critical for determining if a patient is eligible for acute stroke treatments). EDMD stated he decided to consult with the hospitalist to admit Pt 2 for further monitoring and assessment. EDMD stated a cardiology consult was requested after Pt 2 ‘s cardiac condition changed a decrease in Pt 2 ‘s heart rate. EDMD stated he was not alerted to any changes in Pt 2 ‘s mental status; only when she became more bradycardic (heart rate less than 60 beats per minute). EDMD stated he did not feel calling a RRT Stroke Alert in the ED would have changed his medical management. 2. During an interview on 8/1/25 at 8:51 a.m., with Registered Nurse (RN) 13, RN 13 stated upon Pt 2 ‘s return to the unit from a planned procedure, he attempted a full head to toe assessment, and noted odd responses. RN 13 stated he and Pt 2 ‘s son felt Pt 2 was showing left-sided facial droop. RN 13 stated he began a Face, Arm, Speech, and Time (FAST -an acronym used to help identify and remember the key signs of a stroke) exam and called for his Practice Coordinator (PC) to come to Pt 2 ‘s bedside to get a second set of eyes on the patient. After the PC ‘s assessment, the Rapid Response Team (RRT)/Crisis Nurse was called for what staff felt were positive signs of stroke. RN 13 stated that anyone (staff) observing a change in status can call a RRT/crisis nurse. RN 13 explained House Supervisor (HS) 1 responded because the RRT/Crisis Nurse was on another unrelated event. RN 13 stated his PC paged Pt 2 ‘s doctor using the paging system within the hospital electronic medical record (EMR) application. RN 13 stated it was decided not to call a stroke alert by providers after providers assembled at Pt 2 ‘s bedside. The electronic medical record did not include an assessment for Pt 2 at the time the providers were at bedside. During a concurrent interview and record review on 7/31/25 at 2:00 p.m., with the Stroke Program Coordinator (SPC- a healthcare professional, often a registered nurse, who manages and oversees the care of stroke patients within a hospital or healthcare system), Pt 2 ‘s EMR was reviewed. SPC stated Pt 2 ‘s primary RN notified her of Pt 2 ’ s stroke event on 7/2/25 which prompted her review of Pt 2 ’ s admission. SPC explained her role is to collect patient stroke data to ensure the hospital ’ s stroke program functions and meets the program regulatory requirements. SPC stated during her review of Pt 2 ‘s record, she did not find an entry in the electronic medical record by a nurse or physician about the RRT called on 6/29/25. During a telephone interview on 8/1/25 at 1:05 p.m., with House Supervisor (HS) 1, HS 1 stated he responded to the RRT called on 6/29/25 for Pt 2 because the RRT/Crisis RN was on another call. HS 1 stated if there are simultaneous RRT ‘s, the RRT RN triages and will call for help. HS 1 stated the RRT/Crisis RN ‘s back up is the ICU PC however due to his ICU background, the RRT/Crisis nurse called him. HS 1 stated when he got to the unit, Pt 2 ‘s primary RN (RN 13), the unit PC, and Resident doctor (MD) were at Pt 2 ‘s bedside. HS 1 stated he did not take the lead in managing the situation deferring to the doctors that were present. HS 1 stated they (MDs) are the primary driver of medical care. HS 1 stated based on information provided and his assessment of the situation, he decided not to call a stroke alert. HS 1 stated he believed the RRT should have been cancelled because Pt 2 was hemodynamically stable; imaging had already been done and her condition was not “acute” based on response from resident MD. HS 1 stated he did not document his response to Pt 2 ‘s bedside, assessment or outcome of the RRT call. HS 1 stated RRT calls are documented under a separate RRT tab in the EMR, and can also make an entry in a progress note with a summary of the event after the RRT. HS 1 stated he did not document the event because the RRT should have been cancelled. The EMR did not include documentation HS 1 responded to Pt 2 ‘s bedside. During an interview on 8/5/25 at 11:51 a.m. with the hospital Chief Nursing Officer (CNO), CNO stated her expectation is that staff would make entries to the medical record that are accurate, timely, and representative of the patient care delivered to ensure providers have a clear view of the patient ’ s medical course, their response to treatment and meets patient care needs. During a review of hospital P&P titled “Rapid Response Team,” dated 4/2023, the P&P indicated “...PURPOSE: To provide clinical support and medical intervention for patients needing immediate medical attention and emergency care. ... OUTCOME: Early recognition and prompt, appropriate interventions are performed to prevent an actual or potential deterioration in the patient’s condition. DEFINITIONS: Rapid Response Team (RRT): members include RRT nurse, respiratory therapist and on call ICU physician. RRT nurse: an Advanced Cardiac Life Support (ACLS) RN trained in rapid response and emergency care. The RRT nurse may also be called Crisis RN... POLICY: 1. When there is a patient with an actual or potential deteriorating condition, the RRT will be called by staff, family, or patients to seek additional nursing and respiratory therapy assistance to prevent an actual or potential deterioration in a patient condition. PROCEDURE: 1. The person at the bedside determines that the patient is clinically unstable, at high risk of deterioration, or has an acute change in one or more of the following: A. Staff member, patient, or family, “worried” about the patient. There is a perception that the patient requires prompt intervention to prevent further deterioration. ... J. Unexplained agitation or altered mental status that requires immediate intervention. 2. The staff member notifies the practice coordinator. 3. The staff member/primary RN and/or the practice coordinator initiate RRT... 5. Primary RN will notify the attending or cross covering physician of the current changes in patient condition and that an RRT has been called as soon as possible. 6. The staff member/primary RN and practice coordinator will remain at the patient’s bedside to communicate the patient’s status and to assist the team. 7. RRT functions under the Rapid Response Team Standardized Procedure... 8. The RRT nurse returns for a follow-up within four hours after the call for all patients not transferred to Critical Care area. If no follow-up, RRT nurse documents reason...” During a review of hospital Standardized Procedure (SP) titled “Rapid Response Team Standardized Procedure” dated 4/11/25, the SP indicated “...POLICY: A. Function: initiate intervention. The result will provide information enabling the physician to facilitate assessment and treatment in order to prevent further decline in patient condition. B. Circumstances the Crisis Registered Nurse (RN) or back-up Crisis RN may implement: 1. Setting: The Rapid Response Team staff may perform anywhere for registered patients. 2. Supervision: A critical care physician from the hospitalist group will provide supervision and consultation. 3. Patient Condition: The Rapid Response Team may be summoned for reasons including, but not limited to: a. Caregiver or family member concerned about patient ’ s clinical status, having noted an unfavorable change to the patient ’ s clinical presentation. ...e. Acute mental status changes/decreased level of consciousness (LOC) or seizure including acute signs/symptoms of suspected Ce r e b r a l V a s c u l a r A c c i d e n t ( CVA)/stroke... PROTOCOL: ...1.11... A. Definition: a disease in which the functioning of the brain is affected by some agent or condition. B. Data Base: 1. Subjective including, but not limited to, complaint of HA, hypertension, vision changes, paralysis or weakness that is usually unilateral (one-sided), facial droop, dizziness or loss of balance, confusion, inability to articulate or repetitive use of a word or phrase, slurred speech, repetitive yawning, difficulty with reading or writing, change in personality or mood. 2. Objective a. Acute Changes from baseline GCS... Education (patient/family): The Rapid Response Team members are responsible for providing, when the situation allows, education regarding the events surrounding the RRT call with the bedside staff, the patient, and the patient’s family. Follow-up: If the patient remains in a non-ICU environment, the Crisis Nurse will return to the bedside to re-check patient condition within four hours, unless that is not deemed necessary by the Crisis Nurse. Any reason(s) for which no patient follow-up is necessary is/are to be documented on the Rapid Response Team Crisis Nurse Progress Note...” During a review of a professional reference found at https://www.cms.gov/medicare/medicaid-coordination/states/dcoumentation-matters-toolkit titled “Documentation Matters Fact Sheet for Medical Professionals” electronically retrieved on 8/13/25, the professional reference indicated “...Medicaid Medical Record Documentation... Medical professionals are in the business of helping their patients. Patients are their priority, whether the professional is a physician, pharmacist, nurse, therapist, or any of the many other types of medical professionals. Meeting ongoing patient needs such as furnishing and coordinating necessary medical services is impossible without documenting each patient encounter completely, accurately, and in a timely manner. Documentation is often the communication tool used by and between medical professionals. Records not properly documented with all relevant and important facts can prevent the next provider from furnishing sufficient services. The outcome can result in erratic or even dangerous treatment and cause unintended complications. While meeting patient needs is the most important reason for documenting services, it is not the only one. Another reason for documenting medical services includes complying with Federal...and State laws...These laws require Medicaid providers to maintain the records necessary to “fully disclose the extent of the services,” care, and supplies furnished to beneficiaries... as well as support claims billed...” 3. During an interview on 7/29/25 at 3:30 p.m., with Pt 3, Pt 3 stated the doctor ordered a long arm splint that went from his armpit to his palm. Pt 3 stated it (the splint) was one piece of fiberglass with a wrap around it. Pt 3 stated he did not think to ask about the armband being under the splint when it was being applied. Pt 3 stated that 3 days later, his arm was hurting so he went to (Hospital C) where they removed the splint and found the armband. During an interview on 7/31/25 at 10:30 a.m. with Emergency Medical Technician (EMT 1) regarding Pt 3, EMT 1 stated he remembered Pt 3 and stated he placed a long arm splint. EMT 1 stated his routine is to remove rings, armbands, anything that could constrict (tighten). EMT 1 stated he was not aware that he had left the armband on until his manager informed him. EMT 1 stated he “does not know how he overlooked this, he knows he should never put a splint over an armband.” EMT 1 stated he was trained to apply splints prior to starting his job and as part of his yearly training. During a concurrent interview and record review on 7/30/25 at 2:01 p.m., with the ED Director (EDD), the EMR dated 7/22/25 was reviwed. The for EMR for Pt 3 indicated Pt 3 arrived to the ED on 7/22/25 at 5:30 p.m. complaining of elbow and ankle pain after a fall. At 7:04 p.m., Pt 3 went for x-rays of his ankle, elbow and wrist. On 7/22/25 at 9:34 p.m., Physician ’ s Assistant (PA)1 reviewed the x-ray of Pt 3 ’ s elbow which indicated a fracture of the left radial head (broken part of the elbow joint). PA 1 ordered a long arm brace and a sling to keep the arm from moving too much. The EDD stated her expectation is that armbands should always be removed before placing a splint. EDD stated the risk is the development of a pressure sore from the armband being bunched up under the splint, and possible loss of circulation to the arm if the armband is tight or the arm swells. During a review of documentation from (Hospital C), the documentation indicated Pt 3 arrived at (Hospital C) on 7/25/25 at 1:46 a.m. A document titled, “ED Provider Note” indicated, “ ...Chief Complaint: Patient presents with Pain Arm. ... here for evaluation of left arm discomfort. He was seen at [Hospital A] 2 days ago after a trip and fall on outstretched arm. He was told he had a radial head fracture of the left elbow and was put in a long arm splint. He is complaining of wrist discomfort, as he thinks that his hospital wristband is still on underneath the splint. He denies any numbness or weakness in the hand. No new injuries or trauma ... splint removed. Skin intact throughout. No significant swelling to the arm. The [Hospital A] wrist band was removed. Intact range of motion of the left elbow and wrist. Normal radial pulse...” During an interview on 8/5/25 at 11:53 a.m., with the Chief Nursing Officer (CNO), the CNO stated she expects staff to remove the armband and move it to a different location on the patient if they need to apply a splint. The CNO stated having the armband on underneath the splint could lead to skin break down (sores) and possible infection. During a professional reference review retrieved on 8/7/25 from https://pmc.ncbi.nlm.nih.gov/articles/PMC9256326/#:~:text=Wearing%20wristbands%20too%20tightly%20can,disputes%20%5B12%E2%80%9314%5D. indicated, “ ... Wearing wristbands too tightly can lead to slight ligature marks and even affect the blood circulation of the upper limbs, causing unnecessary injuries...””

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 40644 Based on observation and interview, the hospital failed to have an accurate medical record when the delivery note for Patient (Pt) 16 indicated her baby (Pt 20) was delivered by Medical Doctor (MD) 5, when the baby was delivered by Registered Nurse 11. This failure resulted in inaccurate and incomplete medical records and had the potential to compromise patient safety with future medical care and treatment choices. Findings: During a concurrent interview and record review on 7/30/25 at 9:50 a.m. with the Assistant Director of Obstetrics (ADOB), and the Director of Obstetrics (DOB), the ADOB reviewed the Electronic Medical Record (EMR) for Patient (Pt) 16 and reviewed the document titled, “Obstetrical History and Physical” (OB H&P) dated 7/23/25 at 9:23 p.m. the OB H&P indicated Pt 16 was a pregnant woman who came to the hospital with ruptured membranes (her water had broken) on 7/23/25 at 2:30 p.m. and her cervix was dilated to 7 centimeters (10 centimeters is fully dilated). The nursing flowsheet indicated at 10:53 p.m. a notification was sent to MD 5 to alert him that Pt 16 would be ready to deliver soon, was fully dilated and had an urge to push. The response from MD 5 indicated he was doing surgery on another patient and would come as soon as possible. RN 11 delivered Pt 16 ‘s baby (Pt 20) at 11:01 p.m. without a doctor present. The document titled, “L&D Note by [MD 5] indicated, “A controlled vaginal delivery was completed at 11:01 p.m. on 7/23/25 ... The patient was found to be fully dilated, and I was called into the delivery room. The bed was broken and the patient pushed. She delivered a healthy viable neonate ...The patient tolerated the delivery well and is in good and stable condition. I was present throughout the entire delivery.” The ADOB stated, “well, obviously that is not correct. The baby was delivered by a nurse.” The DOB stated, “This is a problem. The delivery note is not complete and isn ‘t accurate.” During an interview 8/5/25 at 10:30 with the Chair of the Department of Obstetrics (MD 6), MD 6 stated, “[MD 5] probably used a pre-completed note that comes as a template in [name of EMR system]. I need to talk to doctors about reading the notes before they sign them.” MD 6 stated she recognizes this as an opportunity for improvement. During a review of the document titled, “Bylaws of the Medical Staff of [name of hospital] (Bylaws)”, dated 2018, the Bylaws indicated, “BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP: The ongoing responsibilities of each Member of the Medical Staff include: ... preparing and completing accurate and complete medical records including electronic records ...””

“HISTORY AND PHYSICAL CFR(s): 482.51(b)(1) Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies: (i) A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, and except as provided under paragraph (b)(1)(iii) of this section. This Standard is not met as evidenced by: 45929 Based on interview, record review and review of professional standards, the hospital failed to ensure a medical history and physical examination was completed and documented no more than 30 days before or 24 hours after admission or registration, when Medical Doctor (MD) 1 did not complete a history and physical (H&P-a comprehensive assessment of a patient ’ s condition and key component of patient care) prior to Patient (Pt) 1’s surgery with anesthesia (the use of medications to induce a temporary loss of sensation or consciousness) on 7/14/25. These failures resulted in Pt 1 to have a surgery performed without her health history being reviewed by MD 1 and passed away on 7/14/25, 2 hours and 41 minutes after surgery started. Findings: During a review of Pt 1 ‘s “H&P Short Form (H&P SF, a non-inpatient version)”, dated 7/3/25, the H&P SF indicated Pt 1 was a 38 year old female with endometriosis (a disease in which tissue similar to the lining of the uterus grows outside the uterus), dysfunctional uterine bleeding (DUB-abnormal uterine bleeding caused by hormone imbalances), and dysmenorrhea (cramps and pain during a period). The H&P SF indicated, past medical/surgical history included hypertension (high blood pressure), no past medical history. Past surgical history included gastric bypass (a type of surgery that alters the stomach and small intestine to promote weight loss), removal of Pt 1 ‘s gallbladder laparoscopically (laparoscopy, surgery which a fiber-optic instrument is inserted through the abdominal wall to view the organs or permit a surgical procedure), allergies were non-steroidal anti-inflammatory drugs, (a class of medications that reduce pain, inflammation, and fever). There were no additional comments on the H&P SF. The H H&P &P SF indicated, “PHYSICAL EXAM: Check box if examination is normal, otherwise findings as documented ...”. The H&P SF indicated boxes were checked for Heart, Neuro (neurological), and Chest/Lungs, while boxes were unchecked for Head/Neck, Airway, GI (gastrointestinal), GU (genital/urinary), and extremities (arms & legs). During a concurrent interview and record review on 7/31/25 at 10:00 a.m. with the Director of Surgical Services (DSS), Pt 1’s “Procedural/Surgical Consent (PSC)” was reviewed. The PSC indicated, Pt 1 was consenting to “... Robotic assisted laparoscopic hysterectomy (a minimally invasive surgical procedure to remove the uterus using robotic technology), right salpingo oophorectomy (a surgical procedure to remove the right ovary and right fallopian tube), left salpingectomy (a surgical procedure to remove the left fallopian tube), cystoscopy (a procedure where a thin, tube-like instrument is used to examine the bladder and where urine exits the body), uterosacral vault suspension (a surgical procedure to reposition the vagina after a removal of the uterus) ...” to be performed by medical Doctor (MD) 1. The PSC was signed by Pt 1 and dated 7/14/25 at 9:00 a.m. The DSS stated the H&P “Update Note” portion of the PSC was not dated or timed and should have been by MD 1. The DSS stated the pre-operative nurses, and the operative nurses should double check to make sure the H&P and “Update note” were completed by the physician during the transfer of the patient to surgery and they did not. During an interview on 8/1/25 at 2:55 p.m. with the Chief Nursing Officer (CNO), the CNO stated the physician is responsible for dating, timing and updateing the H&P or you cannot know when it was done. During a review of Pt 1 ‘s H&P, dated 7/14/25 at 12:45 p.m., the H&P indicated Pt 1 has a past medical history of ADHD (Attention-deficit/hyperactivity disorder), anxiety, Arthritis, GERD (gastroesophageal reflux), and PONV (postoperative nausea and vomiting). The H&P indicated Pt 1 had a past surgical history of bilateral carpel tunnel release (procedure to release pressure on the median nerve in the wrist) and bladder surgery. During review of “Bylaws of the Medical Staff of [name of hospital] (Bylaws)”, dated 2018, the Bylaws indicated “...We strive for excellence while providing compassionate and medically appropriate care...Membership on the Medical Staff is a privilege, which shall be extended only to those individuals who meet and continue to meet the standards, and requirements set forth...Basic Responsibilities of Medical Staff Membership include...providing patients with the quality of care meeting the professional standards for the Medical Staff...preparing and completing accurate and complete medical records including electronic records...to whom the Member provides care in the Hospital...assuring the completion of a physical examination and medical history (H&P) ... complying with all Federal and State statues related to ...patient care...documentation and referral...” During a review of “Department of Surgery Rules and Regulations (RR), dated 3/27/20, the RR indicated, “ ... VIII. GENERAL RULES REGARDING SURGICAL CARE ... A. Medical Records Requirements ... Admitting History & Physical Exams must be dictated or entered in the Electronic Medical Record. Medical Staff Policy MS-139 defines the required content of History and Physical exams for inpatient and outpatient settings. A complete and documented History and Physical within 30 days of the surgery/procedure will be verified prior to surgery or procedure. If the patient is or will be admitted to the hospital, the History and Physical must be dictated and, if not transcribed, a complete handwritten History and Physical will be obtained with the documented transcription number on the record of the History and Physical. A handwritten or short form may be used for documentation providing the H&P has been dictated and a documented transcription number can be placed on the short form. If this is not completed, the patient will not be transported to the operating room. The only exception is if there is a life-threatening emergency for the patient ...”. During a review of a professional reference titled, “Preparing for Surgery? Here ’ s Why a Complete History and Physical is Essential!”, dated 7/31/23, the reference indicated, “ ... Having a complete H&P before surgery is essential for a number of reasons. First, it provides a comprehensive overview of the patient ’ s health and any existing medical conditions that could affect the outcome of the surgery. This information is important for the surgeon to have before they make any decisions regarding the procedure. Second, a complete H&P helps to identify any potential risks associated with the surgery. This includes any allergies the patient may have, any medications they ’ retaking, and any preexisting medical conditions that could complicate the procedure. A complete H&P allows the healthcare provider to make informed decisions about the safety of the procedure and potential risks. Third, a complete H&P can help to identify any underlying medical conditions that could increase the risk of complications, such as high blood pressure or diabetes. This can be especially important for surgeries that involve anesthesia, as these conditions can increase the risk of serious complications. Finally, a complete H&P can provide the surgeon with valuable information about the patient ’ s overall health and medical history, which can help them in their decision-making process. This can include information about the patient ’ s age, lifestyle, and any preexisting conditions that could affect the outcome of the procedure. Medicare requirements for a complete history and physical. The Centers for Medicare and Medicaid Services (CMS) has outlined specific requirements for a complete H&P before surgery. According to the CMS, a complete H&P must include the following elements ... A review of the patient ’ s medical history and current health status ... An assessment of the patient ’ s fitness for the surgery ... A description of any pre-existing medical conditions ... A description of any medications and allergies ... A review of the patient ’ s laboratory and diagnostic tests ...”.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 45929 Based on observation, interview, video recording review, and record review, the hospital failed to protect and promote each patient’s rights when: 1. Patient (Pt) 1 was not kept free from abuse as excessive force was used during a physical transfer patient and application of restraints and Pt 1 sustained a fractured humerus (forearm bone) (Refer to A-0145). 2. Pt 1 right to autonomy and to make informed decisions regarding his care were not protected when no consent for treatment/admission was signed by Pt 1 or his representative (Refer to A-0131). 3. Pt 2 did not recieve care in a safe setting when nursing staff failed to perform and document a complete head to toe physical examination on Patient (Pt) 2 who was born at 38 weeks gestation; inaccurately determined Pt 2 was a normal newborn and notified the pediatrician, initiated standardized newborn orders and inappropriately transferred Pt 2 to the mother-baby unit. (Refer to A-144, finding 2). 4. Pt 35 did not receive care in a safe setting when nursing staff failed to recognize the signs and symptoms of hypoglycemia and did not implement the hypoglycemia protocol. (Refer to A-144, finding 2) The cumulative effect of these systemic problems resulted in the hospital’s inability to provide care in a safe and effective manner in accordance with the statutory-mandated Condition of Participation for Patient Rights.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 45929 Based on interview, record review and review of professional standards of practice, the hospital failed to ensure medical staff operate under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients in the hospital when Medical Doctor 3 did not identify obvious physical anomalies for Patient 2 during newborn physical examination following full-term birth. Patient 2 was determined to have an imperforate anus, a sacral dimple, a single palmar crease on both hands, and facial physical characteristics associated with genetic disorder several hours after Medical Doctor 3 examined Patient 2. These failures resulted in Patient 2 experiencing difficulty passing stool and a delay in implementing care and services to address the imperforate anus and genetic disorder and required immediate transport to higher level of care; and the potential harm of all future babies not being evaluated and examined to provide prompt care for their physical condition. (Refer to A353) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure quality care in a safe setting.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 37529 Based on observations, interviews, and record review, the facility failed to have a well-organized and effective nursing service when: 1. The hospital staff failed to follow hospital policy and procedure (P&P) when they placed Patient (Pt) 1 in four-point restraints (securing both arms and both legs to a bed to restrict movement) without an order and without a Registered Nurse (RN) ’ s and Licensed Independent Practitioner ’ s evaluations in accordance with hospital P&P Patient 1 was restrained from 8:48 p.m. to 9:57 p.m. (a time lapse of 71 minutes) on 1/30/25. (Refer to A-0398, Finding 1) 2. Nursing staff failed to recognize and act on signs and symptoms of hypolycemia for Pt 35 who was born by C-section at 37 weeks gestation in accordance with hospital policies and procedures. These failiures resulted in not meeting the needs of Pt 35, not addressing the hypoglycemia in a timely manner and resulting in the need to transfer to a higher level of care. (Refer to A-0398, Finding 2) 3. The hospital failed to ensure staff stored and/or administered medication in accordance with policy and procedures and/or professional standards of practice. (Refer to A-405) The cumulative effect of these system problems resulted in the hospital’s inability to provide quality nursing care in a safe setting.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 45929 Based on interview and record review, the hospital failed to protect one of 35 sampled patients’ (Patient 1) rights when they did not obtain consent for treatment and admission from Patient (Pt) 1 or Pt 1’s representative. This failure resulted in the loss of Pt 1’s right to autonomy and to make informed decisions regarding his healthcare from 1/30/25 to 2/27/25. Findings: During a review of Pt 1’s “History & Physical (H&P)”, dated 1/31/25, the H&P indicated Pt 1 was found wandering on the highway at night and was brought to the hospital by Emergency Medical Services (EMS) with a complaint of Altered Mental Status (AMS). The H&P indicated Pt 1 had a history of lung cancer (a group of diseases where the cells in the body grow out of control and spread to other parts of the body). During a review of Pt 1’s “Emergency Department Timeline (EDT)”, dated 1/30/25, the EDT indicated Pt 1 arrived at the hospital’s Emergency Department (ED) on 1/30/25 at 8:08 p.m. and was admitted to the hospital on 1/31/25 at 9:18 p.m. The EDT indicated Pt 1’s next of kin (sister) contact information was obtained in the ED on 1/30/24 at 10:23 pm. During a review of Pt 1’s “Discharge Summary (DS)”, dated 2/27/25, the DS indicated Pt 1’s physicians spoke to Pt 1’s sister (Family Member, FM 1) over the phone on 2/11/25 and 2/21/25. The DS indicated FM 1 met with the palliative care (specialized medical care focused on improving the quality of life for people living with serious illnesses) team on 2/18/25. The DS indicated FM 1 was Pt 1’s Supported Decision Maker (SDM, a trusted individual empowered to support decisions for individuals with disabilities) as Pt 1 was unable to follow commands or answer questions. The DS indicated Pt 1 passed away on 2/27/25 after cancer spread to Pt 1’s brain. During a concurrent interview and record review on 7/9/25 at 2:30 p.m. with the Emergency Department Director (EDD), Pt 1’s Electronic Medical Record (EMR) was reviewed. The EDD stated she could not locate Pt 1’s consent for admission and treatment. During an interview on 7/11/25 at 2:45 p.m. with the Director of Quality (DQ), the DQ stated the hospital did not have consent for admission and treatment for Pt 1. The DQ stated there should have been a consent, but it was not obtained. During a review of the hospital’s policy and procedure (P&P) titled, “Informed Consent/Consent Forms”, dated 12/5/24, the P&P indicated, “ ... OUTCOME: Informed consent is obtained after a competent patient (or person legally authorized to make health care decisions on the patient’s behalf) is given sufficient information by the treating physician/provider to make an informed choice, understands the information, and voluntarily agree to be treated (consent) or not to be treated (refusal), thus protecting the patient’s fundamental right to autonomy ... GENERAL INFORMATION ... If a patient is unable to sign the consent, the responsible party may give consent by telephone provided two hospital employees ... whose signatures are on the consent form, listen to the phone consent ... The Consent to Treat Form is signed on the patient’s admission to the hospital prior to administration of treatment, medication or diagnostic procedure ...and scanned to the Electronic Health Record ... The consent form is scanned and is placed in the patient’s chart and becomes a permanent part of the medical record ...”.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to ensure newborns received care in a safe setting for 2 of 4 patients (Patient 2, Patient 35) when: 1. Nursing staff failed to perform and document a complete head to toe physical examination on Patient (Pt) 2 who was born at 38 weeks gestation; inaccurately determined Pt 2 was a normal newborn and notified the pediatrician, initiated standardized newborn orders and inappropriately transferred Pt 2 to the mother-baby unit. The pediatrician and nursing staff on the mother baby unit failed to perform and document newborn assessments in accordance with professional standards and failed to recognize and identify serious abnormalities in Pt 2’s anatomy. Nursing staff failed to identify Pt 2 did not pass stool by twenty-four hours of life. These failures led to a delay in recognition of an imperforate anus (a birth defect that includes the absence of a normal anal opening) and other physical characteristics associated with genetic abnormalities, a delay in stopping feedings, and a delay in transferring Pt 2 to a higher level of care in order to receive the specialized care needed including surgery, which placed Pt 2 at increased risk for morbidity and mortality. 2.The nursing staff failed to recognize the signs and symptoms of hypoglycemia when Patient (Pt) 35 was noted to be jittery at three hours of life, had difficulty maintaining his temperature in spite of warming measures, and was not feeding well or frequently enough, and failed to implement the newborn hypoglycemia protocol. Pt 35 was born by cesarean section at 37 weeks gestation with NICU staff in attendance after heart rate decelerations; Apgar scores were 8 at one minute and 9 at five minutes, The pediatrician was notified of the birth, newborn orders were initiated, and after recovery Pt 35 was transferred to a room on the mother-baby unit with his mother. On the mother baby unit, Pt 35 was noted to be jittery, and the nursing staff failed to obtain a blood glucose, failed to ensure adequate intake of breast milk, or to supplement with human donor milk or formula, and failed to notify the pediatrician. These failures resulted in Pt 35 suffering severe hypoglycemia with seizures and being transferred emergently to a higher level of care Findings 1. During a concurrent interview and record review on 7/8/25 beginning at 1:55 p.m. with the assistant director of OB (ADOB) and postpartum/newborn unit registered nurse (RN 20), RN 20 stated she had worked on the postpartum/nursery unit for nine years. Patient (Pt) 2’s “Delivery Summary,” dated 5/23/25 at 10:07 p.m. indicated Pt 2 was born on 5/23/25 at 10:07 p.m. by uncomplicated spontaneous vaginal delivery. Apgar score (a standardized assessment for infants after delivery with five components: color, heart rate, reflexes, muscle tone, and respiration, each of which is given a score of 0, 1, or 2) at one minute and five minutes of life was 8 (0 points for color). Review of Pt 2’s head to toe assessment on 5/23/25 at 10:10 p.m. performed by the nursery nurse (RN 25) in the delivery room, indicated Pt 2’s face, ears and eyes appeared normal and symmetrical, no assessment of Pt 2’s spine, anus or palms of hands was documented, and there was no mention of the presence or absence of a sacral dimple. There was a place within the electronic record for the nurse to document “Anus/Rectum Evaluation and Tone”, but it was left blank. The ADOB stated she thought the nurse has to click on “GI/additional assessments” to open up that part of the flowsheet. The ADOB was asked if the nurse can annotate (add notes/comments) in the record if she wanted to document something and did not see a place for it. The ADOB confirmed that the nurse can “free text in the record.” Review of the Provider Notification Note dated 5/23/25 at 10:25 p.m., indicated, “New admission: Notified [Name of pediatrician] about mom/NB birth info, Early-Onset Sepsis (EOS) risk 0.03 (very low risk) Group B Streptococcus (A type of bacteria that can cause illness in newborns) negative, Rupture of membranes (ROM) at delivery, clear, late prenatal care, Herpes simplex virus 1 positive (HSV1- a virus that causes cold sores on the mouth), quick delivery, bruised face and oxygen saturation 92-93% 4-6 mins of age at room air. Routine orders in place.”The record indicated after two hours of observation in the delivery room, Pt 2 was transferred with his mom to the postpartum/newborn unit. Review of Pt 2’s head to toe assessment on 5/24/25 at 8:25 a.m., performed by the postpartum/nursery nurse (RN 22), indicated Pt 2’s face, ears and eyes appeared normal and symmetrical, no assessment of Pt 2’s spine, anus or the palms of the hands was documented, and there was no mention of the presence or absence of a sacral dimple. The ADOB confirmed that while the flowsheet did not show the space to document an assessment of the anus the nurse could have free texted that part of her assessment. There was a space for the assessment of “Spine/Back,” however it was left blank. Review of the Newborn History and Physical (H&P) performed by Pt 2’s pediatrician (MD 3) dated 5/24/25 at 9:19 a.m., indicated, “General: Non-dysmorphic appearing infant ...Ears have normal shape and position ...Genitourinary: Normal Tanner 1[refers to the expected size and development of genitalia before puberty], Anus patent. Musculoskeletal: No sacral dimple ...” Review of Pt 2’s head to toe assessments on 5/24/25 at 12:45 p.m. and 4 p.m., performed by RN 22, indicated Pt 2’s face, ears and eyes appeared normal and symmetrical, no assessment of Pt 2’s spine, anus or the palms of the hands was documented, and there was no mention of the presence or absence of a sacral dimple. There was a space for the assessment of “Spine/Back,” however it was left blank. Review of Pt 2’s head to toe assessment on 5/24/25 at 8 p.m. performed by the postpartum/nursery nurse (RN 24) indicated Pt 2’s face, ears and eyes appeared normal and symmetrical, no assessment of Pt 2’s spine, anus or palms of hands was documented, and there was no mention of the presence or absence of a sacral dimple. There was a space for the assessment of “Spine/Back,” however it was left blank. The assessment of Pt 2’s bowel sounds indicated “Absent,” with no comment noted and no reassessment; they had been assessed as being “Active” on each assessment since birth. RN 20 was asked what she would do if she was unable to hear any bowel sounds when she assessed a newborn. RN 20 stated if she finds something abnormal like absent bowel sounds during an assessment, she would document it and notify the pediatrician, and she would reassess the baby. Review of the “Delivery Summary,” dated 5/23/25 at 10:07 p.m., and the “Newborn Intake and Output Flowsheet,” dated 5/23/25 at 10:07 p.m. through 5/25/25 at 01:20 a.m., indicated Pt 2 had no documented bowel movements from the time of birth on 5/23/25 at 10:07 p.m. until 1:20 a.m. on 5/25/25. RN 20 was asked when she would notify the pediatrician if a newborn had not passed meconium (the first stool of a newborn baby) since birth. RN 20 stated she would notify the pediatrician if the baby had not passed stool by 24 hours of life (5/24/25 at 10:07 p.m.) and document it in the record. RN 20 stated there is no documentation in the record indicating the pediatrician was notified either before or after the baby was 24 hours old. Review of the “Provider Notification” note dated 5/25/25 at 2 a.m. indicated, “Called [MD 3] about infant being seen by Nurse Practitioner [NP] of NICU (Neonatal Intensive Care Unit-a specialized unit that provides care for critically ill newborns). Infant appears to not have a patent anus and is in need of a transfer. [MD 3] will be calling NP about discussing a transfer.” Review of the “Provider Notification” note dated 5/25/25 at 2:15 a.m. indicated, “[MD 3] called back after talking to NP in NICU and requested to speak with [Pt 2’s] mother. [MD 3] spoke with Pt 2’s mother via nursery RN cell phone and explained to mother that infant will need to be transferred to [NICU]” Review of the “Significant Event” note dated 5/25/25 at 6:51 a.m., indicated at 1:20 a.m., “Received a call from the mother stating that she wasn’t sure where the baby’s poop was coming from. Entered the room and upon examination, did not see and anal opening and stool was oozing from a tiny hole in the lower left side of the base of the scrotum (the external pouch of skin that holds the testicles). The RN then notified the nursery who then called NICU to come evaluate the patient. Nursery then called [Name of Pediatrician (MD 3)] to notify and evaluate remotely. [MD 3] then spoke to NICU, and they agreed to transfer the patient to NICU for further evaluation. [MD 3] spoke to the mother. Patient was transferred at 2:35 a.m.” During a review of the record from [name of children’s hospital] the neonatology history and physical dated 5/25/25 at 3:34 a.m. indicated, “Genetics: Patient has imperforate anus with small fistula along scrotal sac. Passing small amount of stool through opening in fistula at base of scrotal sac. Will require x-ray, abdominal ultrasound, and echocardiogram [ECHO- a test that uses ultrasound to look at the structure and function of the heart]. Also has sacral dimple (an indentation or pit in the skin on the lower back that can be a sign of a serious spinal problem). Will require ultrasound of spine to rule out additional defect. Baby will remain N.P.O. [no oral intake]; oral gastric tube to low intermittent wall suction. Will transfer to [name of children’s hospital], surgical consult on admission.” During a review of the record from [name of children ’ s hospital] the “Transport Nurses Notes,” dated 5/25/25 at 8 a.m., indicated, “ ...Initial Physiological Assessment ...Gross Abnormalities: Normal appearing genitalia with exception of outlet of stool at the most distal aspect of scrotum. No rectal outlet. Simian crease (a single palmar deep crease can be associate with genetic abnormalities) to both palms. Lower set ears. Eyes close together ...” During a review of the record from [name of children ’ s hospital], the “Pediatric Echocardiogram Report” dated 5/25/25 at 11:22 a.m., indicated, “Small patent ductus arteriosus [PDA- an opening between the two main blood vessels leaving the heart] with a left to right shunt. Small patent foramen ovale [PFO- a hole between the left and right atria (upper chambers) of the heart] with a left-to-right shunt.” During a review of the record from [name of children’s hospital], the “Clinical Genetics Consult Note,” dated 6/11/25 at 10:56 a.m., indicated, “ ...Male presenting with dysmorphic features and multiple congenital anomalies including imperforate anus, abnormal ears and increased nuchal skin. I was asked to consult on this patient given the concern for genetic syndrome. Physical exam: Prominent ears, large, detached lobules, and lobular dimpling. Unilateral single transverse palmer creases ...” During a review of the record from [name of children ’ s hospital], the “Genetics Report,” dated 6/20/25, indicated, “ ...Based on the submitted clinical information, the patient has neonatal hyperbilirubinemia (high levels of bilirubin in a newborns blood), thickened nuchal skin fold, protruding ear, prominent ear helix, large earlobe, anal atresia, abnormal scrotum morphology, rectoperineal fistula, sacral dimple, single transverse palmar crease, hyperechogenic kidneys, patent ductus arteriosus, patent foramen ovale, feeding difficulties in infancy. Results positive: Witteveen-Kolk syndrome, which is characterized by distinctive facial features, microcephaly, short stature, poor pre- and post-natal growth, intellectual disability and developmental delay. Affected individuals may additionally present with ...genitourinary anomalies ...” During an interview on 7/9/25 at 1:20 p.m. with the postpartum/newborn nursery nurse (RN 21), RN 21 stated she was working the night of 5/24/25 from 7 p.m. to 7 a.m. on 5/25/25 and was asked by another RN (RN 24) to assess Pt 2 at around 1:30 a.m. on 5/25/25. RN 21 stated Pt 2 had just had his first bowel movement and there was a question as to where the meconium was coming from. RN 21 stated after the baby’s (Pt 2) bottom was cleaned, she saw meconium oozing out from a tiny hole in the underside of the scrotum on the left. RN 21 stated when she spread apart Pt 2’s buttocks she saw what at first looked like an anus, however when she looked closer, she could see that there was not actually a true opening. RN 21 stated it was necessary to spread apart the baby’s buttocks in order to really visualize it, if someone looked without doing that, the abnormality would not have been seen. RN 21 stated she also noticed on the ridge that runs down the center of the scrotum there were small beads of a whitish material. RN 21 stated she took the baby out of the postpartum room and called the nursery, and a nursery nurse (RN 23) came to assess Pt 2. The nurse practitioner (NP) in the neonatal intensive care unit (NICU) was also notified and responded to check Pt 2. RN 21 stated RN 23 called Pt 2’s pediatrician (MD 3). During an interview on 7/9/25 at 2:10 p.m. with the postpartum nurse (RN 22), RN 22 confirmed she worked the day shift on 5/24/25 and was the nurse assigned to care for Pt 2 and his mom. RN 22 stated she does not remember anything about this baby at all since it had been over a month since she took care of Pt 2 but was told Pt 2 was found to have an imperforate anus. RN 22 stated she has no remembrance of her assessment of Pt 2 but stated she would have done a complete physical assessment every eight hours. RN 22 stated she did not remember whether Pt 2 had his first meconium yet at the time she took care of him, but if Pt 2 had not pooped yet and it had been 24 hours since birth, she would have notified the pediatrician and documented that in the medical record. During an interview on 7/10/25 at 8:10 a.m. with a nursery nurse, (RN 23), RN 23 confirmed she was working in the newborn nursery the night of 5/24/25 from 7 p.m. to 7:30 a.m. on 5/25/25. RN 23 stated around 1:30 a.m. on 5/25/25 she was called by another nurse to come to look at a baby, and then she called the NICU NP. RN 23 stated the NP examined the baby and confirmed the imperforate anus and asked her (RN 23) to call Pt 2 ’ s pediatrician because Pt 2 needed to be transferred to the NICU. RN 23 stated she called the pediatrician (MD 3) and informed him that Pt 2 was examined by the NP and did not have a patent anus and needed to be transferred. RN 23 stated MD 3 started asking questions and RN 23 stated she suggested he speak with the NP. RN 23 stated MD 3 called her back after he spoke with the NP and gave an order to transfer the baby to the NICU. RN 23 stated MD 3 called Pt 2’s mom and explained the situation and let her know the baby (Pt 2) needed to be transferred to the NICU for evaluation. During an interview on 7/10/25 at 8:45 a.m. with a postpartum nurse (RN 24), RN 24 confirmed she worked the night of 5/24/25 from 7 p.m. until 7:30 a.m. on 5/25/25, and was the nurse assigned to care for Pt 2 and his mom. RN 24 stated around 1:20 a.m. on 5/25/25 she was called by Pt 2’s mom who asked her to come to their hospital room to check Pt 2. RN 24 stated when she got to the room Pt 2’s mom was changing Pt 2’s diaper and stated, “I don’t think the poop is coming out of his butt.” RN 24 stated she looked at the baby and saw that meconium was coming out of a tiny hole in the underside of the scrotum on the left and was not coming out of what she thought was the baby’s anus. RN 24 stated she told Pt 2’s mom that she was right, and RN 24 stated she called for a nurse to come into the room to look at the baby, and RN 21 responded. RN 24 stated Pt 2 ’ s mom was upset and crying. RN 24 stated the nursery nurse called the NP and the pediatrician and the baby was transferred to the NICU. RN 24 stated she had assessed Pt 2 soon after her shift started on 5/24/25 and did not recall anything unusual. RN 24 described how she performed a part of the physical assessment stating, she puts the baby in the bassinet and with baby undressed, turns baby on his abdomen, checks the baby ’ s spine to make sure it is straight, checks for a sacral dimple, and spreads the baby’s buttocks to view the anus. RN 24 confirmed the documentation of her assessment of Pt 2 did not include an assessment of the anus. RN 24 stated she had never taken care of a baby with an imperforate anus before and did not notice it looked different. RN 24 was asked when she would notify the pediatrician if a baby did not have a bowel movement, and RN 24 stated if it had been 24 hours since birth and a baby had not had a bowel movement, she would notify the pediatrician and document that in the medical record. During an interview on 7/10/25 at 2 p.m. with a nursery nurse (RN 25), RN 25 confirmed she worked the night of 5/23/25 from 7 p.m. until 7:30 a.m. on 5/24/25 and was in the delivery room when Pt 2 was born. RN 25 stated as long as the baby is stable after delivery, the baby is placed skin to skin on mom. RN 25 stated the vital signs are assessed right away and then sometime within the first hour a full head to toe assessment is completed and documented. RN 25 described her process for performing part of the newborn assessment, and stated she turns the baby over on his abdomen and checks the back for symmetry, checks to see that the spine is straight starting at the top of the spine and follows it down to the sacrum and checks for a dimple. Then she spreads the buttocks and checks the anus. RN 25 stated she does not recall anything abnormal or unusual about this baby. RN 25 stated she was also working the next night and became aware that Pt 2 had been found to have an imperforate anus. RN 25 stated she went to look at the baby herself and stated although she had seen an imperforate anus in the past; in order to see this one it was necessary to really spread open the buttocks to see it. RN 25 stated now she does that every time. RN 25 stated she also noticed all along the ridge running down the center of the baby’s scrotum there were whitish beads that were not there the previous night when she assessed the baby in the delivery room. RN 25 stated her documentation of the newborn head to toe assessment did not include an assessment of the baby’s spine or the anus. During a review of the hospital’s P&P titled, “NEWBORN CARE,” dated 7/24/24, the P&P indicated, “ ...OUTCOME: All newborns will be observed and cared for in a safe and consistent manner. POLICY: The physician will be notified per Provider Notification Algorithm: On admission ... Of any variation from normal. PROCEDURE: Perform a complete assessment every 8 hours after initial assessment. This includes neurological, musculoskeletal, cardiovascular, respiratory, gastrointestinal and genitourinary systems assessments ... DOCUMENTATION: Electronic Health Record serves as documentation tool for newborn. Initiate at birth and complete all charting in system ...” During a review of a Stanford Medicine article titled, “The Newborn Examination,” retrieved from https://med.stanford.edu/newborns/clinical-rotations/residents/residents-newborn-exam.html, the article indicated, “ ...The anus should have a visible orifice within the sphincter. Stool in the diaper is not evidence of patency ...” Review of the reference titled, “Physical Assessment of the Newborn: A Comprehensive Approach to the Art of Physical Examination,” Sixth Edition, 2019, indicated, “ ...The identification of dysmorphic features during the initial physical examination is a crucial first step in the continuum of care for affected infants. About 15% of all newborn babies will have at least one minor malformation, and these often go unnoticed. However, their presence should prompt the practitioner to look for a major malformation, as newborns with one or more minor malformations are more likely to have a major malformation (e.g., causes dysfunction or requires surgical correction) ...Appearance: An inspection is made for deformations and obvious malformations. An abnormal facial appearance or other abnormalities in appearance can indicate the presence of a syndrome. Neck: Redundant skin in the neck may be a feature of some genetic syndromes. Eyes: If spacing appears abnormal, the distance between eyes can be measured and compared to standard values. This part of the examination is especially important if other dysmorphic features that suggest a syndrome are present. Ears: Malformations of the external ear are often associated with syndromes of multiple congenital anomalies that include renal malformations ... Anus: The anus and rectum should be checked carefully for patency, position, and size, for anal sphincter tone, and for abnormalities such as fistulas. Sphincter tone can be assessed by gently stroking the anal area. An anal wink will occur. Absence of an anal wink suggests an abnormality of the central nervous system. If the anus is completely absent, or imperforate, this may be evident immediately ...Trunk and Spine: A dimple without a visible base may indicate the presence of a pilonidal sinus or tract to the spinal cord ... Extremities: Inspection of palm creases should also be included. The presence of a single palmar crease, or simian crease, should be noted. A single palmar crease is common in newborns with trisomy 21, but can also be found in normal infants...” During a review of the reference article titled, “Pediatric Imperforate Anus,” dated 12/19, retrieved from https://emedicine.medscape.com/article/929904-overview, the article indicated, “ ...Newborns with imperforate anus are usually identified upon the first physical examination. Newborns with imperforate anus should not be fed and should receive intravenous hydration ... Malformations in newborns that are missed upon initial examination are often discovered within 24 hours when the newborn is observed to have distention and has failed to pass meconium and a more thorough examination is performed ...During a thorough physical examination, attention should be focused on the abdomen, genitals, rectum, and lower spine. In males, the testicles must be palpated in the scrotum. The perineum is then examined. Perineal fistulas are diagnosed upon discovery of openings on the perineum, meconium or mucus in a small strip running up into the scrotal median raphe ...” During a review of the World Journal of Advance Healthcare Research article titled, “Management of Anorectal Malformation,” dated 6/6/23, the article indicated, “ ...Most of the cases of imperforate anus should be discovered at birth during the initial physical examination. In most instances the lesion will be noticed immediately after birth by simple inspection, but the perineum may look remarkably normal to the casual attendant ...Failure to pull the buttocks a part in the examination of the newborn baby often causes anorectal anomalies to be missed. Most of the low type malformations can be completely diagnosed with certainty by simple inspection ... Beading of mucus or meconium along the median raphe of perineum and scrotum denotes a low imperforate anus in the male ...” Review of the reference titled, “Newborn Examination: Training Manual,” dated 2009, retrieved from https://stacks.cdc.gov/view/cdc/36626/cdc_36626_DS8.pdf, indicated, “ ...Many obvious defects are often missed simply because nobody looked carefully at all parts of the newborn. For example, a defect such as an imperforate (closed) anus is life threatening and might otherwise go unnoticed if not specifically checked ...An imperforate anus is a congenital defect of the anus; there is partial or complete obstruction of the anal opening. During the exam, you should verify that the baby ’ s anus is patent (open). This can be done by stretching the bottom apart with 2 fingers to look at the opening. If you suspect an imperforate anus, you should ask a doctor to see the baby right away. A baby with imperforate anus may still pass meconium if there is another associated abnormality, such as an abnormal connection between the vagina and rectum (recto-vaginal fistula). Therefore, even if you see meconium, you still need to verify the presence of an anal opening ... Look at the baby ’ s back. Pay careful attention to any abnormalities which might be located along the midline or along the spine. Look for birthmarks, dimples, or tufts of hair along the spine. These may be a sign of a more serious problem. Any abnormalities that you find along the midline of the back should be recorded ...” During a review of the World Journal of Pediatric Surgery article titled, “Delayed diagnosis of anorectal malformations,” dated 12/27/2024, the article indicated, “ ...The key to ARM recognition is early perineal examination, specifically-inspection and palpation of the perineum in the neonate soon after birth. Newborn perineal examinations should be incorporated into all newborn guidelines/protocols for birth personnel and documented in postnatal charts. Identification of ARM at the time of birth and early pediatric surgery referral should be the standard of care for children with these anomalies ...” During a review of the Stat Pearls article titled, “Imperforate Anus,” dated 8/28/23, retrieved from https://www.ncbi.nlm.nih.gov/books/NBK549784/, the article indicated, Imperforate anus or anal atresia is a congenital anorectal malformation (ARM) where a normal anal opening is absent at birth. About half of patients with ARM also have anomalies of other organ systems. These most commonly include genitourinary anomalies, vertebral/spinal cord anomalies, craniofacial anomalies, cardiovascular anomalies, spinal cord anomalies, and other gastrointestinal anomalies. ...A thorough examination of the perineum should take place at birth, and after 24 hours. These may reveal a lack of anal opening or a small depression. The presence of a small orifice, not at the normal position of the anus, may indicate a perineal fistula. However, it may take more than 24 hours for the fistula to reveal itself because significant pressure is needed to force meconium through the fistulous opening. Delayed diagnosis may happen in one out of five neonates, despite routine postpartum evaluation. Such a delay may increase morbidity and mortality. These anomalies must be detected early, preferably in the delivery room. Early involvement of neonatologists and pediatric surgeons is vital for treatment planning and timely intervention ...” 2. During a concurrent interview and record review on 7/11/25 at 2:55 p.m. with the ADOB, Pt 35’s medical record was reviewed. Review of the delivery record dated 6/8/25 at 3:11 p.m. indicated Pt 35 was born by repeat cesarean section at 37 weeks gestation, after fetal heart rate decelerations. The ADOB stated the NICU team was in attendance at the delivery per policy due to the decelerations. The baby ’ s Apgar scores were 8 at one minute of life and 9 at five minutes, no resuscitation was required, and care was assumed by the nursery nurse in the delivery room. The record indicated Pt 35 was transferred with his mother to a room on the mother-baby unit on 6/8/25 at 5:49 p.m. Review of the vital signs flowsheet dated 6/8/25 at 3:11 p.m. to 6/9/25 at 6 a.m. indicated Pt 35 temperature was 98.6 degrees Fahrenheit (F) on 6/8/25 at 3:15 p.m. while on the radiant warmer four minutes after birth, then ranged from 97.4 F-98.4 F, with implementation of thermoregulation measures including skin to skin and going back on the radiant warmer again on 6/8/25 at 4:45 p.m., and on 6/9/25 at 5 a.m. Review of Pt 35 ’ s intake and output flowsheet dated 6/8/25 at 3:15 p.m. to 6/9/25 at 6 a.m. indicated Pt 35 breastfed well for 30 minutes on 6/8/25 at 3:55 p.m., attempted to breastfeed at 7:55 p.m., breastfed fair at 9:55 p.m. for 20 minutes, breastfed well on 6/9/25 at 12:30 a.m., and attempted to breastfeed at 3 a.m., with no supplementation with human donor milk or expressed breast milk. Review of the Infant Assessment flowsheet dated 6/8/25 at 3:11 p.m. to 6/9/25 at 6 a.m., indicated on 6/8/25 at 6:10 p.m., the postpartum/nursery nurse indicated an abnormal finding for the neurological assessment noting Pt 35 to be jittery (trembling, shaking). The ADOB stated the record did not indicate any action taken by the nurse, such as having mother breastfeed, supplementing with human donor milk, or expressed breast milk from mother, and the baby ’ s blood glucose (sugar) was not checked. The ADOB stated the hypoglycemia protocol allowed the nurse to check the baby ’ s blood glucose if they have symptoms that could be signs of hypoglycemia even if the baby did not fall into the at-risk category. The flowsheet indicated that after the assessment at 6:10 p.m., no jitteriness was noted by the nursing staff on the mother-baby unit. Review of the nursing note dated 6/9/25 at 8:29 a.m., indicated, “Approximately 4:56 [a.m.] entered patient ’ s room to get baby ’ s weight and latch baby on the breast. 04:57: Found baby blue bundled up in the crib with dim light on. Turned baby on the side and tapped the back. Checked baby with a bright light on and unraveled baby. Baby appeared dusky and floppy. RN ran with baby in the arms to the nursery to the warmer. 0457: NICU and nursery called to the nursery 4 main in postpartum [mother-baby unit]. 0458: NICU at the bedside and Continuous Positive Airway Pressure [CPAP non-invasive respiratory support method that delivers a continuous flow of heated and humidified air and oxygen, providing positive pressure to keep the airways open and improve breathing.] started ... NICU NP at the bedside. 0503: baby on room air. Appears to be pink and 02 saturation 100%. 0506: NICU NP deemed baby to be stable. Postpartum RN assumed care. 0520: Baby under care of nursery ...” The ADOB stated running with a newborn in your arms is not a safe way to transport. Review of the nursing note dated 6/9/25 at 6:07 a.m. indicated, “ ...Baby brought up to the newborn nursery on 6th floor around 0525 to be monitor for 4 hours per MD order due to dusky and floppy episode noted in the room by postpartum RN. Upon unwrapping baby to place on monitor, noted baby was jittery, placed baby on the radiant warmer and blood sugar was checked by [RN 27, a nursery nurse]. Glucometer reading “lo”. This RN called [name of Pt 35 ’ s pediatrician] to update her on baby’s condition and orders were received, while baby was being attended to by [RN 27] ...” Review of the nursing note dated 6/9/25 at 5:48 a.m. indicated, “Attempted to bottle feed baby 24 calorie formula per MD order due to infant’s blood sugar being low. Baby would not suck. Baby began to shake and 02 sat started to drop. CPAP started [see vital sign flow sheet]. NICU team called to come ... Arrived at 5:55 a.m.” Review of the nursing note dated 6/9/25 at 6:06 a.m. indicated, “Newborn transferred to NICU r/t hypoglycemia and desaturation per MD order.” Review of the Neonatology History and Physical, dated 6/9/25 at 11:05 a.m., indicated, “With mother in room. NICU called to assess infant for “pale blue appearance” In nursery. Infant breathing on Its own. VS stable. Infant transitioned to 6th floor maternal nursery for observation. NICU called to evaluate infant for seizure activity. Glucose undetectable on their monitoring. Infant brought to NICU with obvious shaking, dyspnea, and jerking behavior likely 2/2 to hypoglycemia. Oral glucose gel administered, multiple PIV attempts made without success, and emergent low-lying Umbilical Venous Catheter [UVC- a thin catheter inserted into the umbilical vein in order to administer fluids) line placed for STAT [immediate] intravenous fluid bolus administration. Sterile UVC line placed and verified with x-ray. IV fluids started... Repeat glucose obtained and additional bolus administered. Baby has severe hypoglycemia. Needs endocrine consultation ...Likely seizures due to severe hypoglycemia. Baby is on respiratory support, bubble CPAP ...I updated parents at bedside regarding severe hypoglycemia and need for transfer [to a higher level of care] due to subspeciality expertise ...” The record indicated Pt 35 was transferred from the NICU to [name of children ’ s hospital] at 12:23p.m. on 6/29/25. Review of the policy and procedure (P&P) titled, “Hypoglycemia in the Newborn,” dated 7/24, indicated, “ ...At-risk and symptomatic infants are screened for hypoglycemia and interventions initiated as appropriate. The goals of these guidelines are to reduce neurologic impairment due to neonatal hypoglycemia ... Infants with signs and symptoms of hypoglycemia: A. Mild to moderate symptoms: Jitteriness OR tremors OR exaggerated Moro reflex, decreased muscle tone OR lethargy, Pathological poor feeding OR poor sucking, Tachypnea, Bradycardia, Sustained hypothermia, Sweating OR pallor. Severe Symptoms: Apnea or cyanosis, Seizures OR eye rolling, Coma or decreased level of consciousness ... Hypoglycemia screening in a symptomatic infant: A. A Neonate with symptoms of hypoglycemia, which may or may not have risk factors: Screen point of care test [POCT] glucose immediately. If blood sugar is less than 40mg/dl: 1) Feed immediately 2) Notify Provider/NICU consult 3) Order STAT lab blood glucose. If blood sugar is more or equal to 40mg/dl: 1) Feed immediately and recheck POCT in 45 minutes 2) Notify provider ...” During a review of the hospitals’s P&P titled, “NEWBORN CARE,” dated 7/24/24, the P&P indicated, “ ...OUTCOME: All newborns will be observed and cared for in a safe and consistent manner. POLICY: The physician will be notified per Provider Notification Algorithm: On admission ... Of any variation from normal. Notify provider for sustained temperature less than 36.5 Centigrade (97.9 Fahrenheit) PROCEDURE: Perform a complete assessment every 8 hours after initial assessment. This includes neurological, musculoskeletal, cardiovascular, respiratory, gastrointestinal and genitourinary systems assessments ... Feeding the Newborn: Breastfeed the newborn on demand and at least 8 or more feedings in 24 hours ... Complete blood glucose monitoring per WIS Policy and Procedure: Hypoglycemia in the Newborn. DOCUMENTATION: Electronic Health Record serves as documentation tool for newborn. Initiate at birth and complete all charting in system ...” Review of the professional reference from Stanford Medicine, Clinical Guidelines, “Hypoglycemia,” undated, retrieved from https://med.stanford.edu/newborns/clinical-guidelines/hypoglycemia.html, indicated, “Symptomatic hypoglycemia: Prompt intervention is necessary in these cases, with consideration of immediate IV dextrose in the infant who is not well appearing. Symptoms such as suppressible tremors (jitteriness) and sleepiness occur in many infants who do not have hypoglycemia as part of normal newborn transition, so often these are “mild symptoms” of hypoglycemia and less invasive treatment is typically tried prior to IV dextrose. The method for correcting hypoglycemia should be determined by the clinical status of the infant and considerations for how soon the intervention will normalize the glucose level. If an infant overall appears well, attempts can be made to correct hypoglycemia by feeding the infant and/or giving dextrose gel. Glucose absorption from rubbing dextrose gel on a baby ’ s buccal mucosa has similar response time to administering IV dextrose. Additional evaluation for other underlying disorders should also be considered for the symptomatic infant with hypoglycemia, unless symptoms resolve promptly with glucose correction.0-4 hours of life: Any glucose level less than 25 mg/dL in a baby with severe symptoms requires immediate IV fluid therapy. Between 4 - 24 hours of life: Any glucose level less than 45 mg/dL in a baby with severe symptoms requires immediate IV fluid therapy ...””

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 45929 Based on interview, video surveillance review and record review, the hospital failed to ensure one of 35 sampled patients (Patient 1) was free from all forms of abuse and harassment when Patient (Pt) 1 was transferred between gurneys inappropriately, physically restrained with excessive force and sustanied an injury on 1/30/25 in the Emergency Department (ED). This failure resulted in Pt 1 sustaining a fractured left humerus (upper arm) on 1/30/25 while being held down by facility staff, specifically Emergency Department Technician (EDT) 1 who held him arm. Findings During review of an “Entity Reported Incident (ERI)” submitted to the California Department of Public Health (CDPH) on 2/4/25, the ERI indicated, “ ... Date of Alleged Event: 01/30/2025 Time: 8:50 PM ... Description of Event and additional details: On 1/30/25, a 66-year-old male patient with a history of lung cancer was brought in my EMS [Emergency Medical Services] to be evaluated for a 1799 [California 24 hour detention for evaluation initiated by someone other than law enforcement or mental health professional, when a person is deemed a danger to themselves or gravely disabled] as being gravely disabled after he was found wandering around the highway at night. After patient was placed on a 1799 hold by the provider, the patient was asked to remove his hat, shoes, and personal belongings from his pockets, as part of our process for patients on a hold. The patient stood up in a confrontational manner when the public safety officer removed his hat, who then proceeded to bring the patient back down on the EMS gurney. Additional staff entered the room to move patient from the EMS gurney onto an ED [Emergency Department] gurney and the patient’s left arm hyperextended during transfer. The sustained an oblique [slanted] fracture to the upper extremity [arm] ...”. During a review of Pt 1’s “History & Physical (H&P)”, dated 1/31/25, the H&P indicated Pt 1 was found wandering on the highway at night and was brought to the hospital by Emergency Medical Services (EMS) with a complaint of Altered Mental Status (AMS). The H&P indicated Pt 1 had a history of lung cancer (a group of diseases where the cells in the body grow out of control and spread to other parts of the body). During a review of Pt 1’s “Emergency Department Timeline (EDTL)”, dated 1/30/25, the EDTL indicated Pt 1 arrived at the hospital’s Emergency Department (ED) on 1/30/25 at 8:08 p.m. The EDTL indicated Pt 1 was placed on a 1799 hold (California 24- hour detention for evaluation initiated by someone other than law enforcement or mental health professional, when a person is deemed a danger to themselves or gravely disabled) at 8:31 p.m. due to being gravely disabled by MD 2. The EDTL indicated Pt 1 was 6 foot 3 inches and weighed 200 pounds. During a concurrent interview and video review on 7/9/25 at 8:45 a.m. with the Director of Quality (DQ), the ED Directo (EDD) and the Director of Public Safety (DPS), the “Surveillance Video (SV)”, dated 1/30/25, was reviewed. The EDD stated the video was taken in the ambulance bay (EMS entrance to the ED), where lockers for patient possessions are located. The SV had a single viewpoint and no audio. SV began at 8:27 p.m. Pt 1 was wheeled by EMS 1 from the ED into the ambulance bay, sitting on an EMS gurney with his legs hanging off the side. The gurney is placed parallel against the wall under a window leading to the radio room (a room where the ED receives calls from EMS). Public Safety Officer (PSO) 1 enters the ambulance bay and was seen talking to Pt 1, retrieved papers, and gestured to the lockers. The DPS stated PSO 1 was explaining the process of securing Pt 1’s personal items. EMS 2 and Medical Doctor (MD) 1 entered to speak to Pt 1. Pt 1 stands ups face to face with MD 1. MD 1 leaves ambulance bay after two minutes. PSO 2 entered the ambulance bay and stands approximately three feet from Pt 1. PSO 1, PSO 2 and EMS 2 talked to Pt 1 and gestured as if to explain for five minutes. PSO 2 also pointed to the lockers and the video camera. Pt 1 quickly stood and PSO 2 approached Pt 1 and reached out to Pt 1’s right arm. Pt 1 sat down on the gurney. PSO 2 removed Pt 1’s cap and handed it to PSO 1. PSO 2 reached to pull something from Pt 1’s breast pocket with one hand still on Pt 1’s right arm. Pt 1 attempts to stand abruptly and PSO 2 grabbed Pt 1 by the chest and threw Pt 1 on his back on the foot of the EMS gurney. The EMS gurney moved down the wall approximately 12 inches. PSO 1 and PSO 2 reposition Pt 1 with his head at head of the EMS gurney and his feet hanging off the side of the gurney. PSO 1 held Pt 1 legs and stood on Pt 1 left foot. DPS stated PSO 1 stood on the foot to keep Pt 1 from kicking. When asked if Pt 1 was kicking prior to PSO 1 standing on his foot, DPS stated “ ... no ...”. PSO 3 entered and Emergency Department Technician (EDT) 1 and 2 enter with a hospital gurney. PSO 1, PSO 2, PSO 3, EDT 1, EDT 2, EMS1 and EMS 2 attempted to lift Pt 1 in mid-air off the EMS gurney onto the hospital gurney which was parallel to the EMS gurney and three feet apart. Pt 1 was moving his arms and legs, and appeared to be resisting staff’s grasp and the hospital gurney moved farther away from the patient, the gurney appeared to not be locked. Pt 1 continued to struggle and ended up on the floor. All seven staff members held onto Pt 1. Pt 1 was lifted off the floor onto the hospital gurney. Throughout the transfer process from the EMS gurney, EDT 1 held Pt 1’s left wrist with both of EDT 1’s hands, including lifting from the floor. Pt 1 was on the hospital gurney with seven staff members holding him down. Pt 1’s head was turned to the left side and PSO 3 was at the head of the gurney holding his hand against the side of Pt 1’s face with EDT 3’s arm extended for approximately 3 minutes. EDT 1 was holding Pt 1’s left arm hyper-extended (further extended than a relaxed stance) on the gurney holding the shoulder with one hand and the wrist with the other on the edge of the bed. After approximately two minutes EDT 1 releases Pt 1’s left wrist and PSO 3 moved Pt 1’s wrist over his head. EDT 1 brought Pt 1’s left wrist back down extended on the gurney. During the movement, Pt 1’s left arm was notably deformed. At time stamp 8:48 p.m. Pt 1 was secured in four-point restraints. Staff members resumed removing Pt 1’s personal items from his pockets and the video ends. DPS stated PSO 3 no longer worked at the hospital, as he had resigned. During a review of Pt 1’s X-Ray Report (XR), dated 1/31/25, the XR indicated, “ ... Obliquely oriented [at a slant] fracture is seen to the proximal [closer upper arm] humeral diaphysis [long bone of upper arm] with approximately half shaft width distraction [separation] between the principal fracture fragments ...”. During an interview on 7/9/25 at 9:50 a.m. with PSO 2, PSO 2 stated Pt 1 did not seem agitated when PSO 2 entered the room. PSO 2 stated Pt 1 was close to his height (6 foot 5 inches), cooperative, and stood up when PSO 2 entered the room. PSO 2 stated he explained to Pt 1 the process of removing his possessions and pointed to the camera that would record it. PSO 2 stated EMS had told him Pt 1 was a flight risk (would attempt to leave the ED) and so PSO 2 stood in front of Pt 1 to keep him from “ ... taking off ...”. PSO 2 state Pt 1 was cursing and telling staff, “ ... you’re not going touch me. If you do it’s going to be a problem. I’ll f*** [expletive] you up ...”. SPO 2 stated Pt1 reached for PSO 2’s left arm and PSO 2 grabbed Pt 1 with both hands by the chest and laid him down on the EMS gurney. PSO 2 stated he does not remember the gurney moving. During an interview on 7/9/25 at 10:10 a.m. with EDT 1, EDT 1 stated he was in the radio room and heard a bang against the glass, then came in the ambulance bay to help. EDT 1 stated he was holding Pt 1 left arm during the transfer but did not recall where on Pt 1 he placed his hands. During an interview on 7/9/25 at 1:50 p.m. with PSO 1, PSO 1 stated Pt 1 started to get up after PSO 2 handed PSO 1 Pt 1’s cap and PSO 1 turned away. PSO 1 stated PSO 2 put Pt 1 back on the EMS gurney. PSO 1 stated he stood on Pt 1’s foot. PSO 1 stated he saw a staff member holding Pt 1’s left arm down without anything underneath it. PSO 1 stated once on the hospital gurney, Pt 1 complained about his arm and PSO 1 could see it was deformed. During a concurrent interview and record review on 7/10/25 at 1:20 p.m. with Clinical Risk Manager (RM) 1 and the Interim Director of Risk Management (IDRM), the “Root Cause Analysis (RCA, an investigation to determine the cause of an incident)” of Pt 1’s left arm fracture was reviewed. RM 1 stated that during Pt 1’s transfer from the EMS gurney to a hospital gurney and the application of restraints, Pt 1’s left arm was fractured which prompted the need for an RCA. RM 1 stated the RCA team one EDT held Pt 1 by the wrist while lifting him from the floor turning the transfer. The IDRM stated the EDT’s safe patient handling (use of strategies and techniques including assistive devices to minimize the risk of injury to both patients and healthcare workers during the movement and positioning of patients) education from 2024 indicated a pt should be lifted from the floor with a lift device, not by pulling the patient’s limbs. RM 1 stated SPO had not received safe patient handling training. RM 1 stated at the time of the event, EDT and PSO involved had not had Crisis Prevention Institute training (CPI, a specific type of training revolving around de-escalation techniques, behavior management strategies, and as a last resort safe physical intervention techniques). RM 1 stated the RCA indicated the causation of Pt 1’s fracture was EDT 1 holding Pt 1 arm over the edge of the gurney while PSO 3 held Pt 1’s face against the gurney. RM 1 stated the RCA indicated staff did not lock the gurney which contributed to the failed transfer of the patient. RM 1 stated the RCA indicated staff training in CPI was a causal factor in the event. IDRM stated there was no lead in coordinating the transfer and there was an opportunity for additional communication between clinical staff and the PSOs. The IDRM stated the outcome could have been different if the clinical staff had informed the PSOs that Pt 1 was confused. During a review of the hospital policy and procedure (P&P) titled, “Behavioral Health”, dated 11/2023, the P&P indicated, “ ... PURPOSE: To provide mental health screening/assessment and care to patients who ... are gravely disabled .... To ensure they are provided a safe environment and continuum of care ...”. During a review of the hospital policy and procedure (P&P) titled, “Restraint for Patient Safety”, dated 9/2024, the P&P indicated, “ ... OUTCOME ... When a restraint is required, it is managed in such a manner that the rights of the patient are promoted, patient dignity is maintained as much as possible, and inherent risks are minimized ... DEFINITIONS ... Violent Restraints: Restraints used to manage the patient’s violent or self-destructive behavior jeopardizing the immediate physical safety of the patient, staff, or others ... POLICY ... The decision to use a restraint will not be driven by diagnosis, but by individual patient assessment ... Restraint for Violent or Self-Destructive Behavior ... PROCEDURE ... Assessment ... The RN performs the initial assessment ...The RN determines the intervention based on individual patient assessment ...”. During a review of a professional reference titled, “What Do You Do in CPI Training: Inside Insights and Tips (WDY)”, dated 11/15/24, WDY indicated, “ ... Crisis Prevention Institute (CPI) training is an essential program for professionals in healthcare, education, and human services who manage or respond to individuals in crises. The program is designed to equip individuals with the skills to prevent, de-escalate, and safely manage behavioral crises, reducing the likelihood of harm to themselves or others ... empowers professionals with the knowledge and techniques to handle challenging behaviors with confidence, empathy, and safety ... built around the Non-violent Crisis Intervention model ...emphasizes de-escalation strategies and non-physical interventions whenever possible ... assess situation, apply verbal techniques to calm individuals, and, as a last resort, use safe physical intervention techniques if necessary ... CPI training emphasizes the importance of teamwork in crises ...Collaboration and communication are crucial to ensuring safety and success during a crisis ... CPI training benefits anyone working in environments where they may encounter individuals in crisis, such as ... hospitals ... equips you with skills to maintain safety, prevent escalation, and treat individuals with dignity and respect, even during challenging moments ...”.”

“MEDICAL STAFF BYLAWS CFR(s): 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This Standard is not met as evidenced by: 45929 Based on interview, record review and review of professional standards of practice, the hospital failed to ensure medical staff enforced Medical Staff Bylaws, rules and regulations requiring physicians to provide quality and safe care to each patient in accordance with professional standards of practice when Medical Doctor 3 did not identify obvious physical anomalies for Patient 2 during newborn physical examination following full-term birth. Patient 2 was determined to have an imperforate anus, a sacral dimple, a single palmar crease on both hands, and facial physical characteristics associated with genetic disorder several hours after Medical Doctor 3 examined Patient 2. These failures resulted in Patient 2 experiencing difficulty passing stool and a delay in implementing care and services to address the imperforate anus and genetic disorder and required immediate transport to higher level of care; and the potential harm of all future babies not being evaluated and examined to provide prompt care for their physical condition. Findings: Review of the Provider Notification Note dated 5/23/25 at 10:25 p.m., indicated, “New admission: Notified [name of pediatrician] about mom/NB birth info, Early-Onset Sepsis (EOS) risk 0.03 (very low risk), Group B Streptococcus (A type of bacteria that can cause illness in newborns) negative, Rupture of membranes (ROM) at delivery, clear, late prenatal care, Herpes simplex virus 1 positive (HSV1- a virus that causes cold sores on the mouth), quick delivery, bruised face and oxygen saturation 92-93% 4-6 mins of age at room air. Routine orders in place.” The record indicated after two hours of observation in the delivery room, Pt 2 was transferred with his mom to the postpartum/newborn unit. Review of the Newborn History and Physical (H&P) performed by Pt 2 ’ s pediatrician (MD 3), dated 5/24/25 at 9:19 a.m., indicated, “General: Non-dysmorphic appearing infant ...Ears have normal shape and position ...Genitourinary: Normal Tanner 1[refers to the expected size and development of genitalia before puberty], Anus patent. Musculoskeletal: No sacral dimple ...” Review of the “Delivery Summary,” dated 5/23/25 at 10:07 p.m., and the “Newborn Intake and Output Flowsheet,” dated 5/23/25 at 10:07 p.m. through 5/25/25 at 01:20 a.m., indicated Pt 2 had no documented bowel movements from the time of birth on 5/23/25 at 10:07 p.m. until 1:20 a.m. on 5/25/25. RN 20 was asked when she would notify the pediatrician if a newborn had not passed meconium (the first stool of a newborn baby) since birth. RN 20 stated she would notify the pediatrician if the baby had not passed stool by 24 hours of life (5/24/25 at 10:07 p.m.) and document it in the record. RN 20 stated there is no documentation in the record indicating the pediatrician was notified either before or after the baby was 24 hours old. Review of the “Provider Notification” note dated 5/25/25 at 2 a.m. indicated, “Called [MD 3] about infant being seen by Nurse Practitioner [NP] of NICU [Neonatal Intensive Care Unit-a specialized unit that provides care for critically ill newborns]. Infant appears to not have a patent anus and is in need of a transfer. [MD 3] will be calling NP about discussing a transfer.” Review of the “Provider Notification” note dated 5/25/25 at 2:15 a.m. indicated, “[MD 3] called back after talking to NP in NICU and requested to speak with [Pt 2 ’ s] mother. [MD 3] spoke with Pt 2 ’ s mother via nursery RN cell phone and explained to mother that infant will need to be transferred to [NICU]” Review of the “Significant Event” note dated 5/25/25 at 6:51 a.m., indicated at 1:20 a.m., “Received a call from the mother stating that she wasn’t sure where the baby’s poop was coming from. Entered the room and upon examination, did not see an anal opening and stool was oozing from a tiny hole in the lower left side of the base of the scrotum (external pouch of skin holding the testicles). The RN then notified the nursery who then called NICU to come evaluate the patient. Nursery then called [Name of Pediatrician (MD 3)] to notify and evaluate remotely. [MD 3] then spoke to NICU, and they agreed to transfer the patient to NICU for further evaluation. [MD 3] spoke to the mother. Patient was transferred [to Hospital B] at 2:35 a.m.” During a review of the record from [name of children ’ s hospital] the neonatology history and physical dated 5/25/25 at 3:34 a.m. indicated, “Genetics: Patient has imperforate anus with small fistula along scrotal sac. Passing small amount of stool through opening in fistula at base of scrotal sac. Will require x-ray, abdominal ultrasound, and echocardiogram [ECHO- a test that uses ultrasound to look at the structure and function of the heart]. Also has sacral dimple (an indentation or pit in the skin on the lower back that can be a sign of a serious spinal problem). Will require ultrasound of spine to rule out additional defect. Baby will remain N.P.O. [no oral intake]; oral gastric tube to low intermittent wall suction. Will transfer to [name of children ’ s hospital], surgical consult on admission.” During a review of the record from [name of children ’ s hospital] the “Transport Nurses Notes,” dated 5/25/25 at 8 a.m., indicated, “ ...Initial Physiological Assessment ...Gross Abnormalities: Normal appearing genitalia with exception of outlet of stool at the most distal aspect of scrotum. No rectal outlet. Simian crease (a single palmar deep crease which can be associate with genetic abnormalities) to both palms. Lower set ears. Eyes close together ...” During a review of the record from [name of children ’ s hospital], the “Pediatric Echocardiogram Report” dated 5/25/25 at 11:22 a.m., indicated, “Small patent ductus arteriosus [PDA- an opening between the two main blood vessels leaving the heart] with a left to right shunt. Small patent foramen ovale [PFO- a hole between the left and right atria (upper chambers) of the heart] with a left-to-right shunt.” During a review of the record from [name of children ’ s hospital], the “Clinical Genetics Consult Note,” dated 6/11/25 at 10:56 a.m., indicated, “ ...Male presenting with dysmorphic features and multiple congenital anomalies including imperforate anus, abnormal ears and increased nuchal skin. I was asked to consult on this patient given the concern for genetic syndrome. Physical exam: Prominent ears, large, detached lobules, and lobular dimpling. Unilateral single transverse palmer creases ...” During a review of the record from [name of children ’ s hospital], the “Genetics Report,” dated 6/20/25, indicated, “ ...Based on the submitted clinical information, the patient has neonatal hyperbilirubinemia (high levels of bilirubin in a newborns blood), thickened nuchal skin fold, protruding ear, prominent ear helix, large earlobe, anal atresia, abnormal scrotum morphology, rectoperineal fistula, sacral dimple, single transverse palmar crease, hyperechogenic kidneys, patent ductus arteriosus, patent foramen ovale, feeding difficulties in infancy. Results positive: Witteveen-Kolk syndrome, which is characterized by distinctive facial features, microcephaly, short stature, poor pre- and post-natal growth, intellectual disability and developmental delay. Affected individuals may additionally present with ...genitourinary anomalies ...” During a concurrent interview and record review on 7/11/25 at 1:15 p.m. with the Director of Medical Staff Services (DMS), the DMS accessed the document titled, “Ongoing Professional Practice Evaluation (OPPE) indicators. OPPE is a process used by hospitals to monitor the performance and competency of their doctors and other providers on an ongoing basis to help ensure quality of care, identify areas for improvement, and assist with decisions about maintaining or adjusting privileges. Of the 24 indicators on the form, none addressed the quality of the physicians ’ assessment of the patient. The DMS stated, “Specific to pediatrics is just newborn mortality rates that we measure. For referrals to peer review, the indicators include: unplanned transfer to higher level of care ... We don ’ t have an indicator that monitors the quality of the physician ’ s assessment.” The DMS stated the case was referred to Peer Review (a process where medical professionals evaluate the performance of their colleagues, or “peers”) because it triggered the indicator of “Potential missed/misdiagnosis or delay in treatment/consultation or response resulting in significant change in patient treatment plan.” During review of “Bylaws of the Medical Staff of [name of hospital] (Bylaws)”, dated 2018, the Bylaws indicated “...We strive for excellence while providing compassionate and medically appropriate care...Membership on the Medical Staff is a privilege, which shall be extended only to those individuals who meet and continue to meet the standards, and requirements set forth...Basic Responsibilities of Medical Staff Membership include...providing patients with the quality of care meeting the professional standards for the Medical Staff...preparing and completing accurate and complete medical records including electronic records...to whom the Member provides care in the Hospital...assuring the completion of a physical examination and medical history (H&P) ... complying with all Federal and State statues related to ...patient care...documentation and referral...” During a review of the hospital ’ s policy and procedure titled, “NEWBORN CARE,” dated 7/24/24, the P&P indicated, “ ...OUTCOME: All newborns will be observed and cared for in a safe and consistent manner. POLICY: The physician will be notified per Provider Notification Algorithm: On admission ... Of any variation from normal. PROCEDURE: Perform a complete assessment every 8 hours after initial assessment. This includes neurological, musculoskeletal, cardiovascular, respiratory, gastrointestinal and genitourinary systems assessments ... DOCUMENTATION: Electronic Health Record serves as documentation tool for newborn. Initiate at birth and complete all charting in system ...” During a review of a Stanford Medicine article titled, “The Newborn Examination,” retrieved from https://med.stanford.edu/newborns/clinical-rotations/residents/residents-newborn-exam.html, the article indicated, “ ...The anus should have a visible orifice within the sphincter. Stool in the diaper is not evidence of patency ...” Review of the reference titled, “Physical Assessment of the Newborn: A Comprehensive Approach to the Art of Physical Examination,” Sixth Edition, 2019, indicated, “ ...The identification of dysmorphic features during the initial physical examination is a crucial first step in the continuum of care for affected infants. About 15% of all newborn babies will have at least one minor malformation, and these often go unnoticed. However, their presence should prompt the practitioner to look for a major malformation, as newborns with one or more minor malformations are more likely to have a major malformation (e.g., causes dysfunction or requires surgical correction) ...Appearance: An inspection is made for deformations and obvious malformations. An abnormal facial appearance or other abnormalities in appearance can indicate the presence of a syndrome. Neck: Redundant skin in the neck may be a feature of some genetic syndromes. Eyes: If spacing appears abnormal, the distance between eyes can be measured and compared to standard values. This part of the examination is especially important if other dysmorphic features that suggest a syndrome are present. Ears: Malformations of the external ear are often associated with syndromes of multiple congenital anomalies that include renal malformations ... Anus: The anus and rectum should be checked carefully for patency, position, and size, for anal sphincter tone, and for abnormalities such as fistulas. Sphincter tone can be assessed by gently stroking the anal area. An anal wink will occur. Absence of an anal wink suggests an abnormality of the central nervous system. If the anus is completely absent, or imperforate, this may be evident immediately ...Trunk and Spine: A dimple without a visible base may indicate the presence of a pilonidal sinus or tract to the spinal cord ... Extremities: Inspection of palm creases should also be included. The presence of a single palmar crease, or simian crease, should be noted. A single palmar crease is common in newborns with trisomy 21, but can also be found in normal infants...” During a review of the reference article titled, “Pediatric Imperforate Anus,” dated 12/19, retrieved from https://emedicine.medscape.com/article/929904-overview, the article indicated, “ ...Newborns with imperforate anus are usually identified upon the first physical examination. Newborns with imperforate anus should not be fed and should receive intravenous hydration ... Malformations in newborns that are missed upon initial examination are often discovered within 24 hours when the newborn is observed to have distention and has failed to pass meconium and a more thorough examination is performed ...During a thorough physical examination, attention should be focused on the abdomen, genitals, rectum, and lower spine. In males, the testicles must be palpated in the scrotum. The perineum is then examined. Perineal fistulas are diagnosed upon discovery of openings on the perineum, meconium or mucus in a small strip running up into the scrotal median raphe ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 37529 Based on interview, video surveillance review, and record review the hospital staff failed to follow hospital policy and procedure (P&P) for two of six sampled patients (Patient 1 and Patient 35) when: 1. Patient (Pt) 1 was placed in four-point restraints (securing both arms and both legs to a bed to restrict movement) without an order and without a Registered Nurse’s (RN) and Licensed Independent Practitioner’s evaluations in accordance with hospital P&P. Patient 1 was restrained from 8:48 p.m. to 9:57 p.m. (a time lapse of 71 minutes) on 1/30/25. This failure resulted in Patient 1’s left arm being unnecessarily restrained immediately after sustaining an avoidable fracture. 2. Pt 35 was a newborn delivered by C-section at 37 weeks gestation and showed signs of hypoglycemia (low blood glucose [sugar]) at three hours of life, had difficulty maintaining his temperature, and was not feeding well or frequently enough throughout the night, and the nursing staff did not implement the hypoglycemia protocol or notify the physician in accordance with hospital policy and procedures. By the time the first blood glucose was measured almost twelve hours after the first signs of hypoglycemia, it was too low to be measured by the point of care device. These failures resulted in Pt 35 suffering severe hypoglycemia with seizures and being transferred emergently to a higher level of care Findings: 1. During a review of Pt 1’ s “History & Physical (H&P)”, dated 1/31/25, the H&P indicated Pt 1 was found wandering on the highway at night and was brought to the hospital by Emergency Medical Services (EMS) with a complaint of Altered Mental Status (AMS). The H&P indicated Pt 1 had a history of lung cancer (a group of diseases where the cells in the body grow out of control and spread to other parts of the body). During a concurrent interview and review of surveillance video on 7/9/25 at 8:45 a.m. with the Emergency Department Director (EDD), a surveillance video of four-point restraints being placed on Pt 1, dated 1/30/25, was reviewed. During the movement, Pt 1’s left arm was notably deformed. At time stamp 8:48 p.m. Pt 1 was secured in four-point restraints. At the video time stamp of 1/30/25 at 8:46:41 p.m. (8:46 p.m. and 41 seconds) Pt 1 was shown to be secured in four-point restraints. The EDD stated no RN was present in the room when the restraints were applied. During a review of Pt 1 ’ s “Emergency Department Timeline (EDT), dated 1/30/25, the EDT indicated Medical Doctor (MD) 2 documented at 9:09 p.m., “... Nursing informed me that patient had altercation and was being violent with security. He sustained an injury to his left upper extremity with an apparent deformity at the mid humerus [forearm bone] ...”. The EDT indicated a physician face to face evaluation (an in-person evaluation of the patient’s need for restraints) of Pt 1 was completed at 9:57 p.m. The EDT indicated an order for four-point restraints was placed at 9:57 p.m. (one hour and 11 minutes after Pt 1 was restrained). During a review of Pt 1’s X-Ray Report (XR), dated 1/31/25, the XR indicated, “ ... Obliquely oriented [at a slant] fracture is seen to the proximal [closer upper arm] humeral diaphysis [long bone of upper arm] with approximately half shaft width distraction [separation] between the principal fracture fragments ...”. During a concurrent interview and record review on 7/10/25 at 1:20 p.m. with Clinical Risk Manager (RM) 1 and the Interim Director of Risk Management (IDRM), the “Root Cause Analysis (RCA, an investigation to determine the cause of an incident)” of Pt 1 ’ s left arm fracture was reviewed. RM 1 stated that during Pt 1’s transfer from the EMS gurney to a hospital gurney and the application of restraints, Pt 1’s left arm was fractured which prompted the need for an RCA. RM 1 stated the team conducting the RCA noted that orders for Pt 1’s restraints were not placed for more than an hour after the restraints were applied to Pt 1. During a review of the hospital policy and procedure (P&P) titled, “Restraint for Patient Safety”, dated 9/2024, the P&P indicated, “ ... OUTCOME ... When a restraint is required, it is managed in such a manner that the rights of the patient are promoted, patient dignity is maintained as much as possible, and inherent risks are minimized ... DEFINITIONS ... Violent Restraints: Restraints used to manage the patient ’ s violent or self-destructive behavior jeopardizing the immediate physical safety of the patient, staff, or others ... POLICY ... The decision to use a restraint will not be driven by diagnosis, but by individual patient assessment ... Restraint for Violent or Self-Destructive Behavior ... PROCEDURE ... Assessment ... The RN performs the initial assessment ... The RN determines the intervention based on individual patient assessment ... Licensed Independent Practitioner Evaluation and Order ... An order is required and is obtained prior to or concurrently with the application of restraint ... in a clear case of emergency, a patient may be placed in restraint at the discretion of the RN and a verbal or Licensed Independent Practitioner entered order obtained immediately after the restraint has been applied ... A Licensed Independent Practitioner must see and evaluate the patient within one hour of the initiation of violent restraint ...”. During the review of a professional reference titled, “Attitudes toward the use of restraint and restrictive intervention amongst healthcare staff on acute medical and frailty wards-A brief literature review (ATR)”, dated 9/4/19, ATR indicated, “ ... Whilst the use of restraints is often justified to ensure patient care and prevent injury, it is not without consequence. There are physical and psychological health risks such as pressure sores from the inability to mobilize, or the brewing of anger and frustration when denied access to everyday actions ...” 2. During a concurrent interview and record review on 7/11/25 at 2:55 p.m. with the Assistant Director of Obstetrics (ADOB) OB, Pt 35’s medical record was reviewed. Review of the delivery record dated 6/8/25 at 3:11 p.m. indicated Pt 35 was born by repeat cesarean section at 37 weeks gestation, after fetal heart rate decelerations. The ADOB stated the NICU team was in attendance at the delivery per policy due to the decelerations. Review of the vital signs flowsheet dated 6/8/25 at 3:11 p.m. to 6/9/25 at 6 a.m. indicated Pt 35 temperature was 98.6 degrees Fahrenheit (F) on 6/8/25 at 3:15 p.m. while on the radiant warmer four minutes after birth, then ranged from 97.4 F-98.4 F, with implementation of thermoregulation measures including skin to skin and going back on the radiant warmer again on 6/8/25 at 4:45 p.m., and on 6/9/25 at 5 a.m. Review of Pt 35’s intake and output flowsheet dated 6/8/25 at 3:15 p.m. to 6/9/25 at 6 a.m. indicated Pt 35 breastfed well for 30 minutes on 6/8/25 at 3:55 p.m., attempted to breastfeed at 7:55 p.m., breastfed fair at 9:55 p.m. for 20 minutes, breastfed well on 6.9/25 at 12:30 a.m., and attempted to breastfeed at 3 a.m., with no supplementation with human donor milk or expressed breast milk. Review of the Infant Assessment flowsheet dated 6/8/25 at 3:11 p.m. to 6/9/25 at 6 a.m., indicated on 6/8/25 at 6:10 p.m., the postpartum/nursery nurse indicated an abnormal finding for the neurological assessment noting Pt 35 to be jittery (trembling, shaking). The ADOB stated the record did not indicate any action taken by the nurse, such as having mother breastfeed, supplementing with human donor milk, or expressed breast milk from mother, and the baby’s blood glucose (sugar) was not checked. The ADOB stated the hypoglycemia protocol allowed the nurse to check the baby’s blood glucose if they have symptoms that could be signs of hypoglycemia even if the baby did not fall into the at-risk category. Review of the nursing note dated 6/9/25 at 8:29 a.m., indicated, “Approximately 4:56 [a.m.] entered patient’s room to get baby’s weight and latch baby on the breast. 04:57: Found baby blue bundled up in the crib with dim light on. Turned baby on the side and tapped the back. Checked baby with a bright light on and unraveled baby. Baby appeared dusky and floppy. RN ran with baby in the arms to the nursery to the warmer. 0457: NICU and nursery called to the nursery 4 main in postpartum [mother-baby unit]. 0458: NICU at the bedside and Continuous Positive Airway Pressure [CPAP non-invasive respiratory support method that delivers a continuous flow of heated and humidified air and oxygen, providing positive pressure to keep the airways open and improve breathing.] started ... NICU NP at the bedside. 0503: baby on room air. Appears to be pink and 02 saturation 100%. 0506: NICU NP deemed baby to be stable. Postpartum RN assumed care. 0520: Baby under care of nursery ...” Review of the nursing note dated 6/9/25 at 6:07 a.m. indicated, “ ...Baby brought up to the newborn nursery on 6th floor around 0525 a.m. to be monitor for 4 hours per MD order due to dusky and floppy episode noted in the room by postpartum RN. Upon unwrapping baby to place on monitor, noted baby was jittery, placed baby on the radiant warmer and blood sugar was checked by [RN 27, a nursery nurse]. Glucometer reading “lo”. This RN called [name of Pt 35’s pediatrician] to update her on baby’s condition and orders were received, while baby was being attended to by [RN 27] ...” Review of the nursing note dated 6/9/25 at 5:48 a.m. indicated, “Attempted to bottle feed baby 24 calorie formula per MD order due to infant’s blood sugar being low. Baby would not suck. Baby began to shake and 02 sat started to drop. CPAP started [see vital sign flow sheet]. NICU team called to come ... Arrived at 5:55 a.m.” Review of the nursing note dated 6/9/25 at 6:06 a.m. indicated, “Newborn transferred to NICU r/t hypoglycemia and desaturation per MD order.” Review of the Neonatology History and Physical, dated 6/9/25 at 11:05 a.m., indicated, “With mother in room. NICU called to assess infant for “pale blue appearance” In nursery. Infant breathing on Its own. VS stable. Infant transitioned to 6th floor maternal nursery for observation. NICU called to evaluate infant for seizure activity. Glucose undetectable on their monitoring. Infant brought to NICU with obvious shaking, dyspnea, and jerking behavior likely 2/2 to hypoglycemia. Oral glucose gel administered, multiple peripheral intravenous [IV] line attempts made without success, and emergent low-lying Umbilical Venous Catheter [UVC- a thin catheter inserted into the umbilical vein in order to administer fluids] line placed for STAT [immediately, without delay] intravenous fluid bolus administration. Sterile UVC line placed and verified with x-ray. IV fluids started... Repeat glucose obtained and additional bolus administered. Baby has severe hypoglycemia. Needs endocrine consultation ...Likely seizures due to severe hypoglycemia. Baby is on respiratory support, bubble CPAP ...I updated parents at bedside regarding severe hypoglycemia and need for transfer [to a higher level of care] due to subspeciality expertise ...” The record indicated Pt 35 was transferred from the NICU to [Name of Children’s Hospital] at 12:23 p.m. on 6/9/25. Review of the policy and procedure (P&P) titled, “Hypoglycemia in the Newborn,” dated 7/24, indicated, “ ...At-risk and symptomatic infants are screened for hypoglycemia and interventions initiated as appropriate. The goals of these guidelines are to reduce neurologic impairment due to neonatal hypoglycemia ... Infants with signs and symptoms of hypoglycemia: A. Mild to moderate symptoms: Jitteriness OR tremors OR exaggerated Moro reflex, decreased muscle tone OR lethargy, Pathological poor feeding OR poor sucking, Tachypnea, Bradycardia, Sustained hypothermia, Sweating OR pallor. Severe Symptoms: Apnea or cyanosis, Seizures OR eye rolling, Coma or decreased level of consciousness ... Hypoglycemia screening in a symptomatic infant: A. A Neonate with symptoms of hypoglycemia, which may or may not have risk factors: Screen point of care test [POCT] glucose immediately. If blood sugar is less than 40mg/dl: 1) Feed immediately 2) Notify Provider/NICU consult 3) Order STAT lab blood glucose. If blood sugar is more or equal to 40mg/dl: 1) Feed immediately and recheck POCT in 45 minutes 2) Notify provider ...” During a review of the hospital’s P&P titled, “NEWBORN CARE,” dated 7/24/24, the P&P indicated, “ ...OUTCOME: All newborns will be observed and cared for in a safe and consistent manner. POLICY: The physician will be notified per Provider Notification Algorithm: On admission ... Of any variation from normal. Notify provider for sustained temperature less than 36.5 Centigrade (97.9 Fahrenheit) PROCEDURE: Perform a complete assessment every 8 hours after initial assessment. This includes neurological, musculoskeletal, cardiovascular, respiratory, gastrointestinal and genitourinary systems assessments ... Feeding the Newborn: Breastfeed the newborn on demand and at least 8 or more feedings in 24 hours ... Complete blood glucose monitoring per WIS Policy and Procedure: Hypoglycemia in the Newborn. DOCUMENTATION: Electronic Health Record serves as documentation tool for newborn. Initiate at birth and complete all charting in system ...” Review of the professional reference from Stanford Medicine, Clinical Guidelines, “Hypoglycemia,” undated, retrieved from https://med.stanford.edu/newborns/clinical-guidelines/hypoglycemia.html, indicated, “Symptomatic hypoglycemia: Prompt intervention is necessary in these cases, with consideration of immediate IV dextrose in the infant who is not well appearing. Symptoms such as suppressible tremors (jitteriness) and sleepiness occur in many infants who do not have hypoglycemia as part of normal newborn transition, so often these are “mild symptoms” of hypoglycemia and less invasive treatment is typically tried prior to IV dextrose. The method for correcting hypoglycemia should be determined by the clinical status of the infant and considerations for how soon the intervention will normalize the glucose level. If an infant overall appears well, attempts can be made to correct hypoglycemia by feeding the infant and/or giving dextrose gel. Glucose absorption from rubbing dextrose gel on a baby’s buccal mucosa has similar response time to administering IV dextrose. Additional evaluation for other underlying disorders should also be considered for the symptomatic infant with hypoglycemia, unless symptoms resolve promptly with glucose correction. Within the first 4 hours of life: Any glucose level less than 25 mg/dL in a baby with severe symptoms requires immediate IV fluid therapy. Between 4 - 24 hours of life: Any glucose level less than 45 mg/dL in a baby with severe symptoms requires immediate IV fluid therapy ...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 37529 Based on observation, interview, and record review, the hospital failed to ensure staff stored and/or administered medication in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient ’ s care, and/or accepted standards of practice when: 1. Intravenous (IV- intended to go directly into a patient ’ s vein) tubing was not labeled per hospital Policy and Procedure (P&P) and professional standards. 2. One bag of IV Dextrose 5% (a sterile (germ free) fluid used to provide the body with extra water and sugar) did not have an overwrap (a wrapping that goes over the outside of the IV bag) to protect it from contamination and evaporation, which could change the concentration of the sugar in the bag. These failures had the potential to expose patients to illness from infection and possible medication administration dose error. Findings: 1. During a concurrent observation and interview on 7/8/25 at 11:05 a.m., with RN 2, at patient (Pt) 17 ’ s bedside, medication was being given through IV tubing that was not labeled. RN 2 stated IV tubing should be labeled with the date and time, otherwise staff will not know if the IV tubing is expired. RN 2 explained using expired IV tubing can lead to patient harm such as the possibility of infection. During a review of hospital P&P titled “Intravenous (IV) pump, IV Fluid, and IV Medication Administration” dated 10/23, the P&P indicated “...Procedure: ...7. Peripheral IV Tubing Maintenance A. Change IV tubing in a closed system every 96 hours. i. Change IV extension devices and stopcocks every 96 hours with primary tubing change... 9. Labeling A. Label the IV tubing with the date and time it [IV tubing] is due to be changed...” 2. During a concurrent observation and interview on 7/8/25 at 10:15 a.m. with Dir 1 in the Clean Utility Room (a storage room used for patient supplies that are clean) a storage cabinet was observed. One bag of IV Dextrose 5% did not have an overwrap (a wrapping that goes over the outside of the IV bag.) Dir 1 stated all IV fluids must have an outer wrapping per hospital policy to reduce the risk of contamination (spreading germs.) During a concurrent observation and interview on 7/8/25 at 10:30 a.m. with the Practice Coordinator (PC) 1 on 3 West unit, PC 1 stated that IV bags should not have the overwrap removed until right before it is used. PC 1 stated this was to prevent the bag from becoming contaminated. During an interview on 7/11/25 at 3:45 p.m. with the Manager of Quality (MQ), the MQ stated they have looked for a policy that addresses the need to keep IV fluid bags covered with the overwrap, but they could not find one. During a review of an article in the American Journal of Health-System Pharmacy titled, “Expiration dates and removal of IV bag overwrap” retrieved on 7/15/25 from: https://academic.oup.com/ajhp/article-abstract/52/17/1921/5094209 the article indicated, “ ...The overwrap protects against evaporation of the solution, desiccation of the container, drug oxidation, and photochemical inactivation of the drug. Without the barrier, substantial moisture loss may occur, increasing the drug concentration ...The manufacturers of these products recommend removing the overwrap just before the drug or solution is administered ...” During a review of an article in Nursing2025, the Peer-Reviewed Journal of Clinical Excellence titled, “Working Up a Sweat” retrieved on 7/15/25 from https://journals.lww.com/nursing/citation/2002/10000/working_up_a_sweat.6.aspx, the article indicated, “ ... the purpose of the overwrap is to improve shelf life and to stabilize the drug concentration. What happens then if an IV bag is removed from its overwrap and remains unused for days or weeks? Over time, the fluid volume inside the bag decreases and the drug concentration per millimeter increases. In a recent case, examination of an unwrapped 100 milliliter bag showed that its concentration was only 85 milliliters of solution ... Don’t remove the overwrap from any IV bag stored in your unit until you’re ready to use the solution. Check areas where IV bags are stored, including crash carts ...””

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 47205 Based on observation, interview, and record review the hospital failed to ensure that medications were kept locked and secured to prevent unauthorized access when four (4) of 4 automated medication dispensing refrigerators containing patient medications were unlocked. This failure had the potential for unmonitored and unauthorized access to medications by unauthorized individuals, placing the hospital at risk for diversion (medication taken for use by someone other than for whom it is prescribed), of tampering with (intentional modification of products in a way that would make them harmful to the consumer) medications, and medication administration errors. Findings: During a tour, and observation on 7/8/25 of medication rooms on unit 4 North Telemetry at 10:54 a.m., with tour escorts Director of Telemetry and Medical-Surgical, (Dir 3), and Director of Cardiac Services, (Dir 5) “brand name” medication dispensing refrigerators (MDRs) containing patient medications were closed, but not locked. The contents of the MDRs showed patient medications (influenza vaccination, patient specific pre-mixed medication pending future administration, etc.) that might be ordered for a patient. The MDRs also had a separate attached clear box, equipped with a keyed lock containing a controlled substance (lorazepam vials), which was locked. During an interview on 7/8/25 at 10:55 a.m., with tour escorts Dir 2 and Dir 5, Dir 3 stated the MDRs were connected to the “brand name” medication dispensing machine. Dir 3 stated the MDRs were not locked on any of the units toured because they are in a locked medication room. Dir 5 stated the badge entry pad (a security technology that uses electronic ID badges or cards to grant or deny access to buildings or specific areas) ensured only licensed staff (nurses, pharmacy staff, etc.) accessed the medication room. Dir 5 stated this badge-controlled access was sufficient to meet the “secured” requirement as the medications were secured [locked badge entry door into medication room] and could not be accessed by unauthorized staff. Dir 5 explained the process for accessing controlled substances that are stored in the clear locked cubicle was licensed staff accessed the key from the “brand name” automated medication dispensing machine once the lorazepam vial(s) were removed from the box, the staff locked it and returned the key to the “brand name” automated medication dispensing machine. During a concurrent observation and interview on 7/8/25 at 11:21 a.m. with the 4 North Telemetry unit Practice Coordinator (PC) 3, in the unit medication room, PC 3 stated the MDR was routinely unlocked due to the badge entry secured access to the medication room. PC 3 stated only authorized staff (nurses, pharmacy staff, etc.) have access to the medication room and this MDR has a controlled access medication room entry door. During an observation on 7/8/25 at 3:00 p.m., on the 6 North Intensive Care Unit with tour escorts Dir 3, and Dir 5 “brand name” medication dispensing refrigerators (MDRs) containing patient medications were closed, but not locked. The contents of the MDRs showed patient medications that might be ordered for a patient (influenza vaccination, patient specific pre-mixed medication pending future administration, etc.) and an attached clear box, equipped and locked with a keyed lock containing a controlled substance (lorazepam) were stored in the MDRs. During an observation on 7/8/25 at 3:08 p.m., 6 North Surgical with tour escorts Dir 3, and Dir 5 “brand name” medication dispensing refrigerators (MDRs) containing patient medications were closed, but not locked. The contents of the MDRs showed patient medications that might be ordered for a patient (influenza vaccination, patient specific pre-mixed medication pending future administration, etc.) and an attached clear box, equipped and locked, with a keyed lock containing a controlled substance (lorazepam) were stored in the MDRs. During a concurrent observation and interview on 7/8/25 at 3:22 p.m. with the 6 North Surg PC, PC 5 in the unit medication room, PC 5 confirmed the MDR did have a lock key pad affixed to the exterior, however this door remains routinely unlocked, the keypad entry code is not required to access the stocked medications. PC 5 stated the medication refrigerator was behind a badge entry-controlled access to the medication room entry door. During an observation on 7/8/25 at 3:30 p.m., 5 North Telemetry with tour escorts Dir 3, and Dir 5 “brand name” medication dispensing refrigerators (MDRs) containing patient medications were closed, but not locked. The contents of the MDRs showed patient medications that might be ordered for a patient (influenza vaccination, patient specific pre-mixed medication pending future administration, etc.) and an attached clear box, equipped and locked with a keyed lock containing a controlled substance (lorazepam) were stored in the MDRs. During a concurrent observation and interview on 7/8/25 at 3:45 p.m. with the 5 North Tele PC, PC 2 confirmed the MDR doors (two medication rooms on the unit were toured) are routinely unlocked, behind a badge entry-controlled access to the medication room entry doors. During an interview on 7/11/25 at 4:38 p.m., with the Director of Pharmacy (Dir) 6, and the Medication Safety Coordinator (MSC), both Dir 6 and MSC confirmed it is their expectation that all “brand name” automated MDRs are operative (locking). Dir 6 and MSC stated licensed staff gain access after entering a code on the key pad, if one is present, and only after having accessed the patient specific profile through the “brand name” automated dispensing system. MSC explained that not all MDRs are equipped with punch locks, but if a keypad is present, it is expected staff would punch in the code to gain access to the refrigerated medications. MSC and Dir 6 stated “Policy #18 Medications” addresses this expectation. MSC stated he was “concerned now” after learning that several refrigerators had been found unsecured. MSC stated the unsecured MDRs allow staff to bypass the pharmacist’s safety check (ensures the patient is administered the right medication, order, dose, etc.) done prior to releasing the medication to the patient profile for safe administration. MSC stated some of the risks of unsecured MDRs was possible medication diversion, harm to the patient, and potential over or under dosing. During a review of hospital P&P titled “Medications” dated 1/31/25, the P&P indicated “...Policy No. 18 - Storage of Medications... Medication sent from pharmacy will be stored in “brand name” automated medication dispensing machine or in a locked area designated for drug storage as appropriate (i.e., refrigeration). 4. Medications will remain securely stored until time of administration (i.e., do not carry drugs around in your pocket).... Policy No. 20. - Security of Medications in Patient Care Areas...Procedure: 3. Medication refrigerators are kept secured when not in use...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 47205 Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when: 1. Three (3) of seven (7) ice and water dispensing machines sampled had visible white-colored and rough-textured stains on the ice and water chutes. 2. Registered Nurse (RN) 3 failed to perform hand hygiene during a wound dressing change on 7/10/25 per hospital P&P and professional standards. These failures had the potential to allow for the spread of infection to all patients and staff. Findings: 1. During a concurrent observation and interview on 7/8/2025 at 11:25 a.m. with the Director of Telemetry and Medical Surgical (Dir 3) on the 4 North Telemetry unit, the ice and water dispensing machine had visible white-colored and rough-textured stains on the ice and water chutes. During a concurrent interview and observation on 7/8/2025 at 3:40 p.m. with Dir 3, on the 5 North Telemetry Unit two ice and water dispensing machines had visible white-colored and rough-textured stains on the ice and water chutes. Dir 3, escort during the tour of the above (4 North Telemetry and 5 North Telemetry) units, explained the responsibility for ensuring ice and water dispensing machines are clean is a shared responsibility involving unit leadership (PC, Manager), Environmental Services (EVS-housekeeping) and Plant Maintenance. Dir 3 explained EVS staff clean the outside surfaces of the machines daily and hospital maintenance staff performed deep cleaning and maintenance of the internal parts (including the water and ice dispensing chutes) of the ice and water dispensing machines. Dir 3 stated if the machine needs service, Dir 3 expects staff to submit an electronic work order [for service] to Plant Maintenance (department) as needed. Dir 3 stated the potential harm to patients and staff consuming the water and/or ice from these stained machines is infection and illness. During a review of hospital policy and procedure (P&P) titled “Cleaning and Maintenance of Ice Machines - Plant Maintenance” dated 9/10/24, the P&P indicated “...OUTCOME: Ice, which is used in connection with food or drink, shall be from a sanitary source and shall be handled and dispensed in a sanitary manner... POLICY: Each ice machine will have preventive maintenance (PM) cleaning as per the manufacturers recommendations or more frequently as needed... GENERAL INSTRUCTIONS: 1. Environmental service will clean the outside surfaces of all ice machines daily, using hospital approved disinfectant and clean water. Rinse with special attention to cleaning hard water build-up. 2. During routine cleaning and maintenance, Environmental Service will observe any kind and report to supervisor. 3. Maintenance and cleaning procedures of components will occur as specified by the manufacturer or as conditions dictate...” The instructions for use (IFU) for the “brand name” ice and water dispensing machines was requested and not provided. During a review of a professional reference found at https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, titled Appendix C. Water Guidelines for Environmental Infection Control in Health-Care Facilities (2003), the guidelines indicated “...Microorganisms have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that sticks to the surface.)...” During a review of the FDA Federal Food Code, dated 2022, 4-602.11, the Food Code indicated, “ ...ice makers, and ice bins must be cleaned on a routine basis to prevent the development of slime, mold, or soil residues that may contribute to an accumulation of microorganisms.” 2. During a concurrent observation and interview on 7/10/25 at 9:14 a.m., with Registered Nurse (RN) 3 and Practice Coordinator (PC- Charge Nurse) 6, at Pt 14 ’ s bedside, RN 3 did not wash her hands or change her soiled gloves after removing the soiled dressing and before cleaning Pt 14 ’ s wound. RN 3 stated she was cleaning the wound and did not need to clean her hands or change gloves. PC 6 stated it was expected that RN 3 perform hand hygiene and change soiled gloves before moving on to cleaning and dressing the wound. RN 3 removed the soiled gloves, cleaned her hands with an alcohol-based hand sanitizer and applied clean gloves. After applying the clean dressing, RN 3 reached into her uniform pocket with her soiled glove to find a pen to use to date and time the dressing she had just applied. PC 6 stated hand hygiene during dressing changes is important in preventing the spread of infection. RN 3 performs hand hygiene. During an interview on 7/10/25 at 9:14 a.m., with PC 6 and, and Medical Surgical Director (Dir) 1, Dir 1 stated opportunities for hand hygiene were missed during the dressing change and would require follow up. During a review of hospital policy and procedure (P&P) titled “Dressing Change: Dry and Moist to Dry” dated 7/10/25, the P&P indicated “...PURPOSE: To provide guidelines for changing a dry or moist to dry dressing... POLICY: 1. Trained licensed staff will perform dry or moist-to-dry dressing changes... PROCEDURE: “Literary Reference” Procedures: Moist Saline Gauze: Dressing Application...” During a review of a professional reference found at https://www.cdc.gov/infection-control/hcp/core-practices/ titled “Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings” guidance, electronically retrieved from dated7/17/25, indicated “...5. Standard Precautions...5a. Hand Hygiene References and resources: 3, 7, 11... 1. Require healthcare personnel to perform hand hygiene in accordance with Centers for Disease Control and Prevention (CDC) recommendations. 2. Use an alcohol-based hand rub or wash with soap and water for the following clinical indications: a. Immediately before touching a patient b. Before performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices c. Before moving from work on a soiled body site to a clean body site on the same patient d. After touching a patient or the patient ’ s immediate environment e. After contact with blood, body fluids or contaminated surfaces f. Immediately after glove removal...” During a professional reference found at https://www.ncbi.nlm.nih.gov/sites/books/NBK470254/ titled “Hand Hygiene.” dated 2025, indicated “...In 2009, the World Health Organization (WHO) highlighted preset guidelines known as the “Five Moments for Hand Hygiene.” Before touching or coming into contact with a patient; before performing a clean or aseptic procedure... Alcohol-based hand sanitizers are the recommended product for hand hygiene when hands are not visibly soiled. Apply alcohol-based products per manufacturer guidelines on dispensing of the product. Typically, 3 mL to 5 mL in the palm, rubbing vigorously, ensuring all surfaces on both hands get covered, about 20 seconds is required for all surfaces to dry completely...””

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 49538 Based on interview and record review, the facility failed to obtain two signatures on a Consents to Treat (COT-consent to treat and bill the patient) for one of six patients (Pt 19) when Pt 19’s COT did not have a second hospital employee (staff) signature to verify a phone consent according to the hospital’s policy and procedure (P&P) titled, “Informed Consent/Consent Forms.” This failure resulted in Pt 19’s consent to treat to go unverified by a second witness. Findings: During a concurrent interview and record review on 12/5/24 at 11:10 a.m. with Nurse Manager (NM) 7, Pt 19’s “Consent to Treat (COT) Part 2,” dated 11/9/24 was reviewed. The COT Part 2 indicated, “ ...The Patient is unable to sign because: Weakness. If other than patient, indicate relationship: [Name of Family Member] Relative ... Signature of Patient’s Representative: Phone consent ... Signature captured at 11/9/24 4:56 p.m. ... Witness Emp ID#: [Name of Staff] ...” NM 7 stated there was one staff signature on the COT Part 2 form. During a concurrent interview and record review on 12/5/24 at 3:45 p.m. with the Patient Access Supervisor (PAS), Pt 19’s “COT Part 2,” dated 11/9/24 was reviewed. The PAS stated the COT Part 2 indicated a phone consent was given by Pt 19’s family member and there was one staff signature present on the form. The PAS stated hospital staff who obtained the consent should have asked a second hospital staff to witness the consent to treat phone call with the patient’s family member. The PAS stated the hospital’s second staff should hear the patient’s family member give consent. The PAS stated the procedure is for two staff to sign the COT Part 2. The PAS stated there should have been two staff signatures when the phone consent was provided to Pt 19’s family. The PAS stated she expected the second staff to sign the COT Part 2 to validate a conversation about treatment was witnessed and a family member had given consent. The PAS stated facility staff should have followed the facility’s policy. During a review of the facility’s P&P titled, “Informed Consent/Consent Forms,” revised 8/2023, the P&P indicated, “ ...PURPOSE: To provide information to the patient regarding their health status, diagnosis, prognosis and appropriate care, treatment and services options allowing the patient to make an informed choice, as well as, to provide guidelines for completing and witnessing consent forms. OUTCOME: Informed consent is obtained after a competent patient (or person legally authorized to make health care decisions on the patient’s behalf) is given sufficient information by the treating physician to make an informed choice, understands the information, and voluntarily agrees to be treated (consent) or not to be treated (refusal), thus protecting the patient’s fundamental right to autonomy ... GENERAL INFORMATION: ... If a patient is unable to sign the consent, the responsible party may give consent by telephone provided two hospital employees (e.g. RN, Technologist), whose signatures are on the consent form, listen to the phone consent ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 49538 Based on observation, interview and record review, the facility failed to ensure all licensed nurses (LNs) adhered to the hospital’s policies and procedures (P&P), when LNs did not reassess pain after administration of pain medication for one of six patients (Pt 17) according to the facility’s P&P titled, “Pain Management Guidelines.” This failure placed Pt 17 at risk for inadequate pain management or oversedation and could negatively affect the physical, emotional, and psychosocial (the influence of both physical and social factors on an individual) well-being of patients. Findings: During a review of Pt 17’s “History and Physical (H&P-complete patient assessment by physician),” dated 12/2/24, the H&P indicated Pt 17 was a 25-year-old female who was admitted to the Labor and Delivery unit for prolonged decelerations (a sudden and significant decrease in a fetus’s heart rate) at 39 weeks and 4 days gestation (the period of time between conception and birth). During a concurrent interview and record review on 12/4/24 at 2:43 p.m. with Registered Nurse (RN) 4 and Nurse Director 4, Pt 17’s “Pain Assessment Flowsheet,” dated 12/3/24, and “Medication Administration Record (MAR-where medications given to a patient are documented),” dated 12/3/24 were reviewed. The PAF indicated at 8:02 a.m., Pt 17 had a pain of 6 (moderate) out of 10 (Mild Pain=score of 1-3, Moderate Pain=score of 4-6, Severe Pain=score of 7-10). The MAR indicated Pt 17 was administered ibuprofen 600 milligrams (mg-unit of measure) by mouth at 8:02 a.m. RN 4 stated the PAF indicated Pt 17’s pain was not reassessed within one hour after pain medication was administered. RN 4 stated the PAF indicated Pt 17’s next pain assessment was completed at 12:45 p.m . (a lapse of 4 hours and 43 minutes) with a pain of 7 (severe). RN 4 stated it was important to reassess the patient’s pain to determine if the intervention was effective and if more interventions were necessary. ND 4 stated she expected LNs to reassess the patient’s pain within one hour to determine the effectiveness of the intervention. During a review of the facility’s P&P titled, “Pain Management Guidelines,” revised 9/2024, the P&P indicated, “ ...PURPOSE: To provide guidelines for effective pain management including assessment and education to achieve pain relief with minimal risks and safe outcomes. OUTCOME: Patients are timely assessed/re-assessed for pain, educated on their treatment, and managed appropriately for complications ... POLICY: ... Reassessment criteria will be used to evaluate and respond to the patient’s pain ...Documented reassessment will include pain and sedation levels ...Pain reassessment will be done in an appropriate timeframe based on the medication given, and this reassessment documented ... PROCEDURE: ... Assess and reassess pain at regular intervals appropriate for the specific patient including: ... Following pain management interventions, once sufficient time has elapsed for the treatment(s) to be effective ...” During a professional reference review titled, “Pain management in hospitals: patients’ satisfaction and related barriers,” dated 9/25/18, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207353/) indicated, “ ... Suboptimal pain control has been frequently reported in healthcare settings and documented to negatively impact patients’ health. Patients’ perception regarding pain management may influence their satisfaction regarding treatment ...” During a professional reference review titled, “Acute Pain Management Pearls: A Focused Review for the Hospital Clinician,” dated 12/22/22, (found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9818465/) indicated, “ ... Uncontrolled pain worsens patient outcomes ... Uncontrolled acute pain triggers a complex neurohormonal cascade that is toxic to nearly every organ system, as evidenced by increased rates of renal [kidney] and gastrointestinal [stomach and intestine] dysfunction, infection, cardiopulmonary [heart and lungs] and thrombotic [blood clot] complications, impaired wound healing, adverse psychological effects, and poorer functional recovery and quality of life ... Acute pain management in hospitalized patients should therefore be a clinician and intuitional priority as a key driver of patient outcomes ...””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 49538 Based on observation, interviews, and record review, the facility failed to ensure unusable medications were not available for patient use when one liter of lactated ringers’ solution (solution used to replace water and electrolyte loss in patients) was not labeled and dated in the Labor and Delivery (L&D) medication room warmer according to the facility’s policy and procedure (P&P) titled, “Warmers: IV, Irrigation, Blanket.” This failure had the potential for patients to receive altered, ineffective, and contaminated medications. Findings: During a concurrent observation and interview on 12/3/24 at 11:20 a.m. with Nurse Director (ND) 4 and Nurse Manager (NM) 4, in the L&D medication room, one liter of lactated ringers’ solution was not labeled and dated in the warmer. NM 4 stated the one liter of lactated ringers’ solution was not labeled and dated when placed in the warmer. NM 4 stated it could be in the warmer for 48 hours then thrown away if not used. NM 4 stated operating room (OR- where surgical procedures are performed) technicians were responsible to label and stock the intravenous (IV- within a vein) fluids in the warmer. NM 4 stated licensed nurses (LNs) are expected to check for a label and expiration date before patient use. NM 4 stated it was not safe to use on patients if we do not know the expiration date. ND 4 stated the one liter of lactated ringers’ should be thrown away because the expiration date is unknown. During an interview on 12/6/24 at 9:44 a.m. the Director of Quality and Infection Prevention (QIPD), the QIPD stated the integrity of the lactated ringers could be compromised from being in a dark, moist warm environment which can lead to bacterial growth. The QIPD stated bacteria could then be introduced into the blood stream when used on a patient. During a review of the facility’s P&P titled, “Warmers: IV, Irrigation, Blanket,” revised 10/2019, the P&P indicated, “PURPOSE: To provide guidelines for staff to ensure intravenous fluids, irrigation, solutions and blankets which require warming, are kept at an acceptable level. OUTCOME: Temperature is maintained in the warmers appropriate for the types of items being warmed. Items are kept in the warmers based on manufacturer’s recommendations. POLICY: ... Once fluids are removed from the warmer, they must be used within 24 hours. If not used, they must be discarded ... Date marked on sticker is the last day the fluid can be in the warmer ... PROCEDURE: ... Intravenous Fluids (volumes greater than 150ml): A. Date intravenous fluids when placed in the fluid warmer. 1) Place date on sticker to avoid fluid contamination. 2) Date marked on sticker is the date the item must be removed from the warmer. 3) Check dates prior to use. B. Leave the IV overwrap intact during the warming period. 1) If an outer wrap is present, fluid is good for 14 days ...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 45929 Based on observations, interviews, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when: 1. Three unopened soda cans and an unopened hand sanitizer were stored in a cabinet in the dirty utility room (a closed space in healthcare facilities that is used to safely dispose of human waste and clean or dispose of used medical supplies). 2. Two empty soda cans were found in a cabinet in the nourishment room (where food and drink for patients are stored). These failures had the potential for cross contamination (physical movement or transfer of harmful bacteria from one person, object, or place to another) and placed patients at an increased risk for hospital acquired infections (an infection that develops while a person is in a healthcare facility). Findings: During a concurrent observation and interview on 12/3/24 at 11:40 a.m. in the 3rd floor West dirty utility room with Nurse Manager (NM) 3, three full, unopened soda cans and one unopened hand sanitizer refill container were stored in a cabinet. NM 3 stated the soda cans and sanitizer container were now dirty, having been in the dirty utility room. During a concurrent observation and interview on 12/3/24 at 11:45 in the 3rd floor West nourishment room with Registered Nurse (RN) 1, RN 1 stated the used cans should not be stored in the nourishment room cabinet. During an interview on 12/3/24 at 11:50 a.m. with Infection Preventionist (IP) 1, IP 1 stated the soda cans in the dirty utility room and the empty cans in the nourishment room were considered dirty items and should not be in there. During an interview on 12/6/24 at 9:44 a.m. with the Quality & Infection Prevention Director (QIPD), the QIPD stated the unopened hand sanitizer and unopened soda cans should not have been stored in the dirty utility room. The QIPD stated unopened cans should have been thrown out because they could have been exposed to bacteria or microbes (tiny organisms invisible to the naked eye). The QIPD stated the used soda cans should not have been stored in the nourishment room because they grow microbes and cross contaminate patient food. During a review of a professional reference from the Agency for Healthcare Research and Quality (AHRQ) titled, “Infection Prevention (IP)” (undated), “IP” indicated, “ ... Providing a sanitary environment ... There is a clear separation of clean and dirty work areas. Clean areas are used for storage and preparation of medications and unused supplies; dirty areas are used for contaminated equipment ...”. During a review of the professional reference titled, “The role of the surface environment in healthcare-associated infections (RS)”, dated 8/2013, the “RS” indicated, “ ... Hospital surfaces are frequently contaminated with important healthcare-associated pathogens [bacteria]. Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider’s hands or gloves that may result in patient-to-patient transmission of nosocomial [originating from the hospital] pathogens ...”.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 49230 Based on observation, interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA for five of 21 patients, Patients (Pts) 1, 3, 4, 8 and 18 when: 1.The hospital failed to provide an appropriate medical screen exam (MSE) for four of 21 patients (Patient 1, Patient 4, Patient 8 and Patient 18) when: Patient 1 a homeless patient was brought in by ambulance (BIBA) with a complaint of leg pain and was told by Registered Nurse (RN) 3 he could not be registered and seen in the ED; no MSE was done. Patient 4, a homeless patient was discharged from Emergency Department on 8/14/24 without an appropriate medical screening exam and discharge was not done in accordance with hospital homeless discharge policy. Patient 8 was a 38 weeks 5 days pregnant woman who presented to Obstetrics Emergency Department (OBED) with a chief compliant of chest pain, and shortness breath, she was seen in OBED, cleared by an OB provider (physician who cares for women and their babies during pregnancy and childbirth), and was taken to main ED for a cardiac work up and was placed in the lobby after triage. Patient 8 was not assessed in accordance with the facility policy and medical screening exam was not started for over eight hours. Patient 18, who was 21-week pregnant women was triaged in OBED the Medical Screening Exam (MSE) and triage assessment did not include fetal heart rate (FHR) in accordance with hospital policy prior to sending the patient to the main emergency department and eventual transfer to Hospital B behavioral health facility on 6/22/24. (Refer to A 2406) 2.The hospital failed to provide stabilizing treatment within their capabilities for one of 21 patients, (Patient 3), with emergency medical conditions when Pt 3 was brought in by ambulance (BIBA) on 8/14/24 to the hospital ED with altered mental status, history of insulin dependent diabetes, high blood glucose and high blood pressure. An appropriate MSE was conducted by the ED physician and Pt 3 was discharged with high blood glucose and high potassium and the admission altered mental status had not improved. (Refer to A2407)”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 45929 Based on interview and record review, the hospital failed to provide an appropriate medical screening examination (MSE, an assessment performed by a Qualified Medical Personnel [QMP] for the purpose of determining whether an Emergency Medical Condition [EMC] exists) for four of 21 sampled patients (Patient (Pt) 1, Pt 4, Pt 8 and Pt 18 when: 1. Patient (Pt) 1 came by ambulance to the Emergency Department (ED) on 6/4/24 at 7:55 p.m. with a chief complaint of leg pain and was told by Registered Nurse (RN) 3 he could not be registered and seen in the ED. No MSE was done. This failure resulted in the hospital not determining whether an Emergency Medical Condition (EMC) existed which placed Pt 1 at risk of harm, injury and possibly death. 2. Pt 4 was found in hospital gown on streets and was brought to the hospital emergency department by Emergency Medical Services (EMS) on 8/14/24. Pt 4 was a homeless patient that had been discharged from the hospital’s inpatient unit on 8/13/24. Pt 4 was subsequently discharged from Emergency Department on 8/14/24 without appropriate medical screening exam and discharge was not done in accordance with hospital homeless discharge policy. This failure resulted in Pt 4 returning to ED three hours and nine minutes after his first ED discharge on 8/14/24. Pt 4 was found to be positive for COVID (SARS-COV-2 respiratory infection) and was admitted for congestive heart failure (CHF-long term condition when the heart cannot pump blood well enough for the body) exacerbation. 3. Pt 8 was 38 weeks 5 days pregnant woman who presented to Obstetrics Emergency Department (OBED) with a chief compliant of chest pain, and shortness breath, she was seen in OBED, cleared by an OB provider (physician who cares for women and their babies during pregnancy and childbirth), and was taken to main ED for a cardiac work up. Pt 8 was assigned Emergency Severity Index (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) of 2 and was placed in the lobby after triage. Pt 8 was not assessed in accordance with the facility policy and medical screening exam was not started for over eight hours. Pt 8 eloped from the main waiting room with abnormal labs and was not called by the hospital staff or provider in accordance with the hospital policy. This failure had the potential for adverse outcome including cardiac arrest for Pt 8 and placed her and her unborn child at risk of harm. 4. Pt 18, who was 21-weeks pregnant was triaged in Obstetric Emergency Department (OBED) on 6/21/24 and the Medical Screening Exam (MSE) and triage assessment did not include fetal heart rate (FHR) in accordance with hospital policy prior to sending the patient to the main emergency department and eventual transfer to Hospital B behavioral health facility on 6/22/24. This failure had the potential for an inaccurate Maternal Fetal Triage Index (MFTI - The MFTI is a five-level obstetric acuity tool for nurses to use when they triage a woman presenting for care to a birth unit in order to prioritize the woman’s urgency for provider evaluation) evaluation and placed the unborn child at risk of harm or injury. Findings: 1. During a review of the “ED 48-hour Return Report (RR, log indicating patient return visits to the ED within a 48-hour period)”, dated 6/2024, the “RR” indicated Pt 1 came to the ED on 6/4/24 at 2:29 a.m., 12:17 p.m., and 7:55 p.m. During a review of Pt 1’s “ED Patient Care Timeline (PCT)”, dated 6/4/24 at 2:28 a.m., the “PCT” indicated Pt 1 came to the ED with the chief complaint of chronic left knee pain with medication prescribed by Pt 1’s Primary Care Physician (PCP) was not helping. The “PCT” indicated Pt 1 was administered ketorolac (a non-steroidal anti-inflammatory for pain), acetaminophen (medication to treat pain and fever) and a lidocaine patch (a local numbing medication applied to the skin, which provides pain relief for 8 - 12 hours). The “PCT” indicated Pt 1 was discharged at 8:33 a.m. During a review of Pt 1’s “ED Provider Notes (PN)”, dated 6/4/24, indicated Pt 1 was discharged without any prescriptions and was instructed to follow up with a family medicine physician and schedule an appointment with orthopedics (physicians specializing in the musculoskeletal system). During a review of Pt 1’s “Emergency Medical Services Run Sheet (RS, a record of ambulance services)”, dated 6/4/24 at 11:43 a.m., the “RS” indicated, “ ... Pt states he has been drinking. Pt called us out for leg pain and being intoxicated. Leg pain been going on for 20 years ... Pt allowed crew to assess ... per pt request he was transported to [hospital name] ...”. During a review of Pt 1’s “PCT”, dated 6/4/24 at 12:17 p.m., the “PCT” indicated Pt 1 arrived I the ED at 12:17 p.m. with a chief complaint of alcohol intoxication and left leg pain for more than 20 years with a current pain score of 6/10 (scale of 0-10, 10 being the worst pain). The “PCT” indicated Pt 1 was assessed for violence using the Broset Violence Checklist (checklist to assess for short-term prediction of violence and an absence of behavior gives a sum score of zero) and Pt 1’s sum score = 0 at 12:23 p.m. The “PCT” indicated Pt 1 was placed in a room at 12:30 p.m. the “PCT” indicated, “ ... 12:31 [p.m.] ... Patient BIBA [brought in by ambulance] for alcohol intoxication and left knee pain x 1 year. Patient was previously here this morning at 0200 [2:00 a.m.]. Has been given multiple resources multiple times. Patient unruly, verbally abusive to md [medical doctor], able to ambulate while holding onto things due to knee pain. No increased wob [work of breathing]. Noted to have wet pants due to incontinence. No vomiting or distress noted at this time ... RN 5 ... 06/04/24 12:34 [p.m.] ...”. The “PCT” indicated, “ ... 12:40 [p.m.] ... ED disposition set to Discharge ... [MD {Medical Doctor} 1] ... 12:47 [p.m.] ... Patient is not cooperating with interview or propose workup, and as such will be discharged ... [Scribe 1, an individual who documents for the physician] ... 12:48 [p.m.] ... Patient refused to sign discharge paperwork. Advised that he has been given resources multiple times and chooses to keep getting drunk. Security at bedside. Tech [ED Technician] at bedside with wheelchair to wheel patient out. he has cell phone to be able to call for a ride ... RN 5 ... 13:00 [1:00 p.m.] ... Patient discharged ... RN 5 ...”. During an interview on 9/5/24 at 1:05 p.m. with RN 5, RN 5 stated Pt 1 was in the ED on 6/4/24 for his second visit of the day and he was intoxicated per EMS, “ ... you could see it in his eyes ...”, and belligerent and cursing at the doctor. RN 5 stated the doctor only requested a Road test (a test for intoxication by having the person walk a straight line) and she believed the physician attempted to complete an MSE. RN 5 stated Security escorted him out after approximately 30 minutes. During a review of Pt 1’s “PN”, dated 6/4/24 at 12:17 p.m., the “PN” indicated, “ ... Chief Complaint: leg Pain and Alcohol Intoxication (+ [positive for] ETOH [scientific reference to alcohol] with last ETOH at approx. [approximately] 1130 [11:30 a.m.] which a pint of liquor [sic]. Pt also with left leg pain for 20+ years per pt) ... History limited to due pt [sic] being aggressive and showing anger ...Review of Systems [ROS] Reason unable to perform ROS: aggression and anger ... Physical Exam ... Constitutional [a symptom indicating general effect of a disease]: ... Patient is very upset, verbally aggressive, refusing to follow any directions ... Musculoskeletal ... patient is very angry, and will not allow me to examine his knee ... Neurological ...He is alert and oriented to person, place, and time ... Stable ambulation with left limp at baseline ... Psychiatric ... Mood normal. Affect is angry ... Behavior is agitated and aggressive ... Thought content normal ... Judgement is impulsive ...Speaking in non-slurred speech ... Medical Decision Making ... patient is very well-known to me with multiple previous visits, was here at 2 AM this morning and eloped ... On instigating conversation with him, he he [sic] became increasingly upset ... ED Course ... 1247 [12:47 p.m.] ... Patient not cooperating with interview or proposed workup, and as such will be discharged ...”. During a review of Pt 1’s “RS”, dated 6/4/24 at 7:20 p.m., the “RS” indicated, “ ... Pt complains of chronic L [left] knee ... pain scaled 10/10, that is constant ... Pt requests to be taken to [hospital name] ... Upon arrival to [hospital name], the pt sat in a wheelchair and was taken to the lobby. [Hospital name] nurse refused to sign the pt into their care because the pt has been to their ED 3x [3 times] today ...”. The “RS” indicated, “ ... Refused ...” on the signature line for Transfer Receiver of patient care. During a concurrent interview and record review on 9/5/24 at 9:10 a.m. with the Emergency Department Director (EDD), Pt 1’s “ED Patient Care Timeline (PCT)”, dated 6/4/24 at 8:10 p.m., was reviewed. The EDD stated she was made aware of Pt 1 being turned away on 6/5/24 from an anonymous report. The EDD stated she and Risk Management began to investigate the incident. The EDD stated the hospital surveillance video was viewed and showed Pt 1 was never registered and RN 3 talked to Pt 1 outside. The EDD stated the video showed Pt 1 left the hospital. The “PCT” indicated, “ ... 6/4/24 ... 19:55 [7:55 p.m.] ... Patient arrived in ED ... [Regional Patient Access Manager (RPAM)] ... 20:10 [8:10 p.m.] ... Patient dismissed ... RN 7 ...”. The EDD stated she had the RPAM document the arrival of Pt 1 retrospectively (after the fact) because the RPAM knew how to document retrospectively. When asked if Pt 1’s “PCT” was accurate, the EDD stated she believed it was accurate and captured Pt 1’s arrival to the ED even though Pt 1 was not allowed to register in the ED. The EDD stated RN 3 dismissed Pt 1 and was under the impression patients returning within 24 hours with the same complaint and no new issues did not need another MSE. The EDD stated during the investigation, other staff were under the same impression. The EDD stated 100% of patients seeking care at the ED need to be registered at every encounter. During a concurrent interview and record review on 9/5/24 at 10:55 with Risk Manager (RM) and the Director of West Region Risk Management & Safety (DRM), Pt 1’s “Root Cause Analysis and Investigation Communication (RCA)”, dated 6/5/24, was reviewed. The “RCA” indicated a possible EMTALA violation summary was sent to senior leadership prior to the investigation and the concern was a patient was not offered a MSE twice on 6/4/24. The “RCA” indicated Risk Management recommended a legal representative review and the legal representative determined the facility did not have to self-report the EMTALA violation. The RM stated senior leadership made the decision not to self-report the violation to the Centers for Medicare and Medicaid Services (CMS). The “RCA” indicated interviews were conducted with staff, Pt 1’s chart was reviewed, and video surveillance was viewed. The RM stated it was determined there was a “ ... cultural normalized deviance ...” from policy. The “RCA” indicated the Former Director of Quality (FDQ) recommended a “ ... book of action [record of actions taken] ...”, as the California Department of Public Health (CDPH) would probably find the violation on an EMTALA Revisit Survey for the 3/2024 EMTALA Survey, while asking for six months review the “ED 48-Hour Return Reports”. During a concurrent interview on 9/6/24 at 8:06 a.m. with RN 3, RN 3 stated she was in the role of Patient Coordinator (PC) and she was aware of Pt 1’s previous visits on 6/4/24 when she received report in the afternoon. RN 3 stated she was notified by a Patient Access Registrar (PAR) when Pt 1 arrived on the third visit. RN 3 stated the PARs did not usually notify her of patient’s arrivals, but the PARs were informed not to register Pt 1 again by the day shift PC (RN 2). RN 3 stated she told Pt 1 he could not be registered and seen in the ED on 6/4/24. RN 3 stated when she was oriented to her job, she was told if a patient returned with the same complaint and no new issues, she was not to register the patient. RN 3 stated she has worked in EDs for 18 years and her understanding of Federal Emergency Medical Treatment and Labor Act (EMTALA) regulations was a MSE was good for 24 hours. RN 3 stated she now has a very different understanding of EMTALA. During a review of the facility’s policy and procedure titled “Emergency Care Services (ECS)”, dated 2/2024, the “ECS” indicated, “ ... Outcome: To Provide care in a safe and consistent manner for patient’s receiving care in the emergency department ... Policy: Triage: ... Patient access will perform a quick registration process on all patients entering the Emergency Department ... Emergency Severity Index (ESI) Score will be given after initial assessment by a trained triage RN ... All patients who seek care will be offered a medical screening exam (MSE) by ED provider ...”. During a review of the facility’s policy and procedure titled “Emergency Medical Treatment and Labor Act (EMTALA) Compliance (EMTALA)”, dated 6/2024, the “EMTALA” indicated, “ ... Procedure ... Examination and Treatment ... The Hospital will provide an MSE, within the capacity of the Hospital, for purposes of determining whether an EMC exists, to the following individuals ... any individual presenting at a DED [Dedicated Emergency Department] seeking examination and treatment of a medical condition ... any individual presenting on Hospital Property other than a DED seeking examination and treatment of a potential EMC ...”. 49230 2. During a review of Pt 4’s “Ambulance report”, with date of service 8/14/24 at 7:48 a.m., the “Ambulance report” indicated, “ ...Incident Address: Surface Street ...The patient has no specific complaint. He has cough, some [shortness of breath (SOB)] with exertion and some occasional swelling/edema to his lower extremities, however, nothing new or acute. He was seen at the [Emergency Department (ED)] yesterday and evaluated [without] any diagnosis. He is not very compliant with his medications for his [blood pressure] and heart failure. He is still in his hospital gown and socks from his visit yesterday ...” During a concurrent interview and record review on 9/5/24 at 10:45 a.m. with the Emergency Department Director (EDD) and Quality Analyst (QA) 1, Pt 4’s medical record was reviewed for his ED visit on 8/14/24. The document titled “Patient Care Timeline” dated 8/14/24 was reviewed and indicated Pt 4, 69-year-old Male, was brought into ED by ambulance on 8/14/24 at 8:22 a.m. The ED chief complaint was “weakness- generalized ...here yesterday, states we didn’t tell him what’s wrong. States he’s living in transitional living. Everything done yesterday”’. On 8/14/24 at 8:25 a.m. Pt 4 was assigned ESI level 3. Initial vitals on 8/14/24 at 8:25 a.m. indicated Heart Rate 83 beats per minute (bpm) (normal 60-100), Temperature 36.6, Blood Pressure (BP) 151/109 millimeters of mercury (mmHg - Unit of measurement)(normal 120/80), Oxygen saturation 92% (spo2- a measurement of the amount of oxygen in the blood) (normal 95- 100%). On 8/14/241 at 10:03 a.m. physician was assigned, and medical screening exam (MSE) was started. X-ray (a quick, painless test that captures images of the structures inside the body) for shoulder and ibuprofen was ordered on 8/14/24 at 10:06 a.m. Pain assessment on 8/14/24 at 10:10 a.m. indicated right shoulder pain level of 6 (1-10 pain scale is a numeric scale that measures pain from 0-no pain to 10-the worst pain possible). On 8/14/24 at 10:07 a.m. Pt 4 received ibuprofen 600 mg. On 8/14/24 X-ray of the shoulder was completed at 10:39 a.m., and at 10:43 a.m. Pt 4’s disposition was set to discharge. On 8/14/24 at 11:21 a.m. documentation by licensed practical nurse (LPN) indicated Pt 4’s Spo2 was 88% and ED physician was notified. The Spo2 on 8/14/24 at 11:23 a.m. were 96%. The EDD stated documentation by LPN on 11:33 a.m. indicated, “ Patient received discharge instructions from provider and has no further questions at this time, [Vitals Signs Stable] ...[Alert and oriented x4 (A&Ox4 - is a medical term that means someone is fully alert and oriented to their person, place, time, and situation)], GCS 15. Ambulatory with steady gait out ED Exit. Per patient he lives in a home with 5 others and there will be someone home to open door to him. Patient did not want bus token stated he doesn’t have to pay when he takes bus [Pt 4 was provided fluids to drink per EDD] “. Pt 4 was discharged on 8/14/24 at 11:35 a.m. During a concurrent interview and record review on 9/5/24 at 10:50 a.m. with the EDD and QA 1, Pt 4’s medical record was reviewed for his first ED visit on 8/14/24. The document titled “[name of facility] Emergency Department Note” dated 8/14/24 was reviewed. The document indicated, “ ...Past Medical History ... Acute on chronic systolic Congestive Heart Failure [serious condition that occurs when the heart is unable to pump blood efficiently] ... Anemia [problem of not having enough healthy red blood cells or hemoglobin to carry oxygen to the body’s tissue] ...Benign Hypertension [high blood pressure] ...Chronic Kidney Disease, stage III (kidneys have mild to moderate damage, and they are less able to filter waste and fluid out of your blood), History of COPD [a common lung disease causing restricted airflow and breathing problems], Type 2 Diabetes Mellitus with chronic kidney disease without long term use of insulin[used as a medication to treat diabetes] ...Patient presents with mild shoulder pain and was found to have mild noninfectious arthritis. He is resting comfortably and safe for discharge and was advised outpatient follow-up with primary care. Emergent return precautions given ...”. The EDD stated Pt 4 only received X-ray of the shoulder and ibuprofen during the ED visit. The EDD stated no labs, chest X-ray or other interventions were done during the ED visit. The EDD stated she looked at the previous encounter and Pt 4 was admitted in the hospital from 8/7/13 to 8/13/24 for CHF exacerbation and was discharged on 8/13/24, a day before the ED visit. The EDD stated the record reflected patient was discharged to an address and unable to comment why the patient was discharged in hospital gown and socks. The EDD validated the patient was flagged as homeless to the ED visit on 8/14/24 and was found on streets by EMS. The EDD stated Pt 4 was a return patient to ED with significant past medical history of cardiomyopathy (caused heart to loose its ability to pump effectively) with poor ejection fraction (a measurement of the percentage of blood leaving the heart each time it squeezes) of 20% and it was unclear that patient had resources as an outpatient for follow up. The EDD stated she would have expected lab work for CHF exacerbation if the provider had concerns about CHF. The EDD stated she was unable to comment why the Pt 4 was discharged again on the first ED visit on 8/14/24 without homeless checklist being completed, and without social worker evaluation. The EDD stated Pt 4 was found on street and brought back in hospital gown and she would have expected Pt 4 to be evaluated for appropriate outpatient follow up and resources prior to discharge on the first ED visit on 8/14/24. During a review of Pt 4’s “Ambulance report”, with date of service 8/14/24 at 2:28 a.m., the “Ambulance report” indicated, “ ...[complaint of] weakness and feeling hungry. Pt release from [hospital name] walking across lawn to [ City bus service name ] bus requesting 911. [upon arrival] pt sitting on bus requesting ice water and food. Pt currently homeless. No [Chest Pain]- [shortness of breath]. Neuro intact. Ambulatory to scene. No obvious trauma. Pt taken back to [facility] for reevaluation ...” During a concurrent interview and record review on 9/5/24 at 11:05 a.m. with the EDD and QA 1, Pt 4’s medical record was reviewed for his second visit on 8/14/24. The documented titled “Patient Care Timeline “ dated for 8/14/24 for his second ED visit indicated Pt 4 was brought back to ED on 8/14/24 at 2:44 p.m. three hours and nine minutes after his previous ED discharge. Pt 4 was assigned ESI of 4 on 8/14/24 at 2:49 p.m. and Pt 4’s chief complaint indicated “Weakness- Generalized (seen and treated here today, recent discharge at 11:14 [a.m.]. Told [company name] bus driver he was weak and tired; bus driver called EMS for transport to ED. Here for shoulder pain. Wants ice water and food)”. Initial vitals on 8/14/24 at 2:50 p.m. indicated HR 82 bpm (normal 60-100), BP 150/85 mmHg (120/80), Spo2 97% (95-100%). The “Patient Care Timeline” indicated medical screening exam (MSE) was started at 6:08 p.m., order was placed for blood glucose testing at 6:11 p.m., MSE was completed 6:12 p.m. The order for blood glucose testing was discontinued at 6:12 p.m. and Pt 4’s disposition was set to Discharge. Pt received discharged instructions on 8/14/24 at 7:01 p.m. On 8/14/24 at 7:37 p.m. Pt 4’s vitals indicated HR 93 bpm (normal 60-100), BP 169/95 (normal 120/80), Spo2 90% (normal 95 -100%). On 8/14/24 at 7:42 p.m. nursing note indicate, “Pt [oxygen saturation] 90-92% on room air. [Physician name] notified. On 8/14/24 at 7:43 p.m. orders were placed for labs that includes B-Type Natriuretic Peptide (BNP - is a blood test that measures levels of a protein called BNP that is made by heart and blood vessels. BNP levels are higher than normal in heart failure), Comprehensive Metabolic Panel (CMP - a routine blood test that measures 14 substances in the blood to provide information about your overall health), troponin (a blood test that detects a protein found in heart muscle cells. This test can help diagnose heart injury and acute coronary syndrome earlier than other tests), CBC and differential (blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells) and other tests that includes 12- lead-EKG (a medical test that measures the heart’s electrical activity and records it on graphed paper), XR Chest (projection radiograph of the chest used to diagnose conditions affecting the chest) 2 views. On 8/14/24 at 8:05 p.m. Pt 4 Spo2 was 98% on 2 lpm oxygen. Pt 4 received albuterol (medication used to prevent and treat wheezing, difficulty breathing, chest tightness, and coughing caused by lung diseases such as asthma and COPD) 2.5 mg & ipratropium (medication that treats lung diseases and conditions, help relax airways and make it easier to breath) 0.5 mg via nebulization at 8:18 p.m. on 8/14/24. Pt 4 also received dexamethasone (medication help immune system control inflammation) 10 mg intravenous (administer into Vein) at 8:26 p.m. On 8/14/24 at 8:48 p.m. CMP results indicated Blood Urea Nitrogen (BUN- test that can help diagnose or monitor kidney disease or disorders) 53 mg/dL (normal range 8-21), Creatinine (creatinine lab test measures the amount of creatinine in the blood to evaluate how well kidneys are working) 1.21 mg/dL, total bilirubin (test use to assess how well liver is functioning) 2.4 mg/dL (normal 0.1-1.3), BNP 4, 221 pcg/ml (normal 0-100). On 8/14/24 at 9:10 p.m. results of troponin high sensitivity indicated 75 ng/L ( normal 0-20) . On 8/14/24 at 9:17 p.m. Respiratory Virus Panel results indicated Pt 4 was positive for SARS-COV-2 (COVID) (normal-not detected). On 8/14/23 at 11:48 p.m. Pt 4’s ED disposition was set to Admit to inpatient. Pt 4 was admitted to inpatient on 8/15/24 at 12:12 a.m. The EDD stated in reviewing the record, Pt 4 was being discharged again without any lab work or testing after a MSE was completed. ED nurse found low Spo2 and escalated to physician and upon further work up patient found positive for COVID. During a concurrent interview and record review on 9/5/24 at 11:15 a.m. with the EDD and QA 1, Pt 4’s medical record was reviewed for his second visit on date 8/14/24. The documented titled “[hospital name] Emergency Department note” was reviewed. The document indicated, “ ...Medical Decision Making ...This is a 69 [year old] male who presented to the Emergency Department due to Weakness-Generalized (Seen and treated here today, recent discharge at 11:14[a.m.]. Told the bus driver he was weak and tired; bus driver called EMS for transfer to ED. Here for shoulder pain. Wants ice water and food) Patient seen here earlier today for shoulder pain and was discharged. His return complaint was that he was hungry, on his physical exam he was ambulatory, well-appearing ...During the time of discharge [he] was found to be hypoxic. The warranted further work up, and patient was found to be in CHF exacerbation with COVID-19. He was ultimately admitted to medicine services ...”. The EDD stated Pt 4 returned after three hours and nine minutes later after discharged from ED visit. The EDD stated labs are ordered based on clinical presentation of the patient and physician assessment. The EDD stated, Pt 4 was a known patient with CHF, 20% ejection fraction, returning to ED within one day of inpatient discharge, found in hospital gown on streets, Pt 4 should have been evaluated more thoroughly for his complaint of generalized weakness. The EDD stated this patient was identified as homeless and the homeless discharge checklist was not completed as per hospital policy prior to Pt 4’s first discharge on 8/14/24. During a concurrent interview and record review on 9/9/24 at 3:35 p.m. with the Emergency Department Medical Director (EDMD) and Emergency Department Manager (EDM), Pt 4’s medical record was reviewed for the both ED visits on 8/14/24. The EDMD stated [physician name] was the ED provider for the patient. The EDMD stated the physician was not concerned about Pt 4’s CHF. The EDMD stated the medical record did not reflect that Pt 4 was tachypneic (abnormally rapid and shallow breathing) or hypoxic (low levels of oxygen in your body) on his first visit. The EDMD stated it would be dependent on provider’s assessment whether patient needed further evaluation. The EDMD stated behavioral health is a big challenge and the ED is like revolving door for some of these homeless patients. The EDMD validated with EDM that Pt 4 had seven visits to ED since 1/1/24 and was admitted four out the seven times. The EDMD stated that Pt 4 was very fragile patient and “ a small bag of chips can put patient in CHF exacerbation, high sodium level”. The EDMD stated Pt 4 did return in three hours and nine minutes, tested positive for COVID and was found to be in CHF exacerbation. The EDMD stated labs work and additional testing would have helped to identify that on the first visit, however, the provider assessment medical decision making did not reflect that it was needed. The EDMD stated the facility has been working on discharge instruction process and it could be better to avoid gaps. During a concurrent interview and record review on 9/9/24 at 3:45 p.m. with the EDM, the EDM stated she had reviewed the medical record for Pt 4. The EDM stated she would have expected the nursing staff to have advocated for the patient and asked the provider about further testing and lab work on the first visit to ED on 8/14/24 since this patient was a known patient and had a previous encounter 24 hours ago. The EDM stated a homeless discharge checklist is a requirement and she was not able to find it in the medical record. The EDM stated the patient returned in hospital gown, was found on street and should have been evaluated for a need for resources according to policy prior to ED discharge. During a review of the facility’s policy and procedure (P&P) titled, “EMERGENCY DEPARTMENT ARRIVAL (TRIAGE), DOCUMENTATION, AND DISCHARGE” with a reviewed date of February 2024, the P&P indicated, “ ...Discharge ...All patient discharged from the Emergency Department will receive appropriate discharge instructions including information regarding any necessary follow up care and instructions on medication, devices and diagnosis ...The nurse will involve other resources deemed necessary to facilitate a safe discharge ...” During a review of the facility’s policy and procedure (P&P) titled, “Emergency Medical Treatment and Labor Act (EMTALA) Compliance”, with a reviewed date of June 2024, the “P&P” indicated, “ ... Policy Statement ...Any individuals who comes to [Hospital Name] (the “Hospital”) seeking an examination and treatment of potential emergency medical condition will receive a screening examination to determine the existence of any emergency medical condition, necessary stabilizing treatment for any emergency medical condition, and if necessary, an appropriate transfer to another medical facility, without regard to the individual’s ability to pay or method of payment ...Treatment of Individual with an [emergency medical condition]exists, the Hospital shall: provide further examination and treatment, within the capability of the Hospital, until the individual’s condition is stabilized; or provide for an appropriate transfer of an un-stabilized individual to another medical facility as set forth in this policy ...” During a review of the facility’s policy and procedure (P&P) titled, “Clinical Protocol- Homeless Patients”, with a review date of March 2022, the “P&P” indicated, “ ...Purpose: To assist homeless patients in managing health conditions (to include behavioral health) while supporting discharge planning arrangements for ongoing care and supportive needs ...The needs of homeless patients for emotional support and discharge needs will be assessed by the clinical Social Work Staff. Individual discharge plans will be developed with consideration of each patient right to self- determination and the availability within the community to link patients with appropriate resources ...Procedure: Inpatient and Emergency Department: ...Review of medical record specific to:.. Patient face sheet- age, address ...Most current nursing observation and notes ...Most current notes by physician ...Determine support systems, access to follow-up material care, medication, and basic needs, including safe housing, food, weather-appropriate clothing, transportation ...Assess coping skills and orientation ...Make appropriate referrals ...The clinical social worker assumes primary responsibility for working with the patient regarding discharge plants, exploring and arranging for community housing options, access to needed medication/medical follow-up ...The Clinical Social worker shall coordinate with the treating staff to ensure, in compliance with SB 1152, the homeless Patient Discharge Checklist (Appendix A) is completed and signed off upon all involved disciplines; upon completion, placing the checklist in to patient’s physical (dark blue) chart to be scanned into the EMR. 3. During a concurrent interview and record review on 9/5/24 at 2:20 p.m. with Obstetric Emergency Department (OBED) Charge Nurse (CN) 1 and Registered Nurse Manager Consultant (RNMC), Pt 8’s medical record was reviewed for the OBED & Emergency Department (ED) visit dated 7/7/24. The document titled “Patient Care Timeline (PCT)” indicated, “...[9:28 p.m.] Patient arrived in L&D [9:39 p.m.] Patient transferred ...bed ...Chief complaints ...Chest Pain [Supraventricular tachycardia -SVT- a condition that causes the heart to beat abnormally fast, usually originating in the upper part of the heart], ...[9:40 p.m.] Primary Assessment ...[oxygen saturation - the amount of oxygen carried by red blood cells (normal 95-100%)] 98% ...Vital Sings ...Temp 36.8..Heart Rate 89 [normal 60-100] ...Respirations 16 [normal 12-20] ...BP..128/84 [normal 120/80] ...[9:50] ...Heart Rate 100 [normal 60-100 ...[10:08 p.m.] Labor ...Membrane Status: Intact ...[10:13 p.m.] [Elector Cardiogram- (EKG- a test to record the electrical signals in the heart was performed)] ...[10:14 p.m.] Labor ...Acceleration ( Accelerations are a sign that the fetus has an adequate supply of oxygen)15x15 ...Decelerations (Deceleration occurs when the FHR temporarily slows during labor): Absent ...Mode: External [Ultra Sound - imaging test that uses sound waves to make pictures of organs, tissues, and other structures inside your body] ... Variability (refers to the variation in a fetus’s heart rate (FHR) and is an indicator of the autonomic nervous system’s response - normal range 5-25 beats per minute (bpm)) ... Baseline FHR bpm: 145 [normal 120-160 bpm] ...[10:30 p.m.].. Patient transferred into ED ...[10:37] p.m. ... Triage Completed ...Acuity Patient Acuity 2 ...[ emergency severity index (ESI) level 2 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious)] ...Chief complaints updated Chest pain (Pt came in from OBED for chest pain onset [6:00 a.m.] this morning, describes it as crushing pain, endorses swelling in extremities, and SOB, Pt is 38 weeks pregnant, cleared by OB ...Pt is GCS 15 ...[10:39 p.m.] lab ordered CBC AND DIFFERENTIAL (blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells), BASIC METABOLIC PANEL (BMP- measures eight different substances in your blood. It provides important information about your body’s fluid balance),TROPONIN I High Sensitivity (measures the level of troponin in the blood to help diagnose heart conditions) ...[10:46 p.m. ] Vital Signs ...Heart Rate 100 (normal 60-100) ... Resp 16 (normal 12-20) ... BP 122/96 (normal 120/80)...Pain Score: 5 - Moderate assessment.. Pain Type ...Acute Pain ...Pain Location: Chest ...Pain descriptors: Tightness ...Pain frequency: Constant ...[11:18 p.m.] CBC auto differential resulted ...Hematocrit (is a percentage of red blood cells in your blood, low level can indicate a number of possible conditions like blood loss, anemia, etc.): 34.4% (normal 37-47) ...[11:37 p.m.] Basic Metabolic Panel Resulted ...Sodium 134 [Millimoles per liter (mmol/L) is a unit of measurement used to report the concentration of a substance in a fluid (normal 135-145)], Potassium: 3.3 mmol/L (normal 3.3-5.5) ...[Blood urea nitrogen - (BUN -measures how much urea nitrogen is in your blood. It helps a healthcare provider determine if kidneys are working as they should)] 6 [milligram per deciliter (mg/dL)- Unit of measurement] ...[10:38 p.m.]Patient transferred ...from room BQ-01 to RW-1 ...[11:44 p.m.] Troponin ...3 [nanograms per liter (ng/L -Unit of measurement) (normal 0-14)] ... 7/8/24..6:15 [a.m.] ...Remove attending ...6:16 [a.m.] waiting for provider status selected ...8:03 [a.m.] Room Call ...Call 3x (No answer in waiting room or outside) ...8:06 [a.m.] ... Patient called in lobby three separate times with no answer ...Pt left ED without being seen ...8:07 [a.m.] Patient discharged ...” During a concurrent interview and record review on 9/5/24 at 2:25 p.m. with OBED CN 1 and RNMC, Pt 8’s “Patient Care Timeline (PCT)” medical record was reviewed for the OBED & Emergency Department (ED) visit dated 7/7/24. The CN 1 validated Pt 8 arrived to the OBED triage directly and was placed in a room in 11 minutes. The CN1 stated nursing documentation reflect [physician name] OB physician was at bedside at 9:39 p.m. Pt 8 was seen by OB physician and EKG was ordered at 9:59 p.m. The CN 1 stated EKG was completed at 10:13 p.m. and Pt 8 was taken to main emergency room for 10:30 p.m. after being cleared by OB physician for active labor or pregnancy related issues. The CN 1 stated Pt 8 still had active chest pain and needed a medical clearance and cardiac work up in the main emergency room. The CN 1 stated the PCT reflected Pt 8 was triaged in main ED at 10:37 p.m. and labs were ordered. The CN 1 validated the record reflected the transition between ED provider and OB provider did not occur until 6:15 a.m. on 7/8/24. The CN 1 stated she was unable to find any documented patient contacts or vitals after 11:38 p.m. and would have to defer to main ED leadership for any questions after the patient was transferred out of OBED. The CN 1 stated the OBED process is to call main ED charge nurse on shift and the charge nurse determines the patient placement for pregnant women coming out of OBED to main ED. CN 1 stated the ED charge nurse determines whether the pregnant patient needs main triage or Emergency Medical Services (EMS) triage in the main ED. During a concurrent interview and record review on 9/5/24 at 2:30 p.m. with OBED CN 1 and RNMC, Pt 8’s medical record was reviewed for the OBED and ED visit dated 7/7/24. The document titled “ED Provider Notes” filed on 7/7/24 at 10:22 p.m. was reviewed. The “ED Provider Note” indicated, “ ...[Pt 8] is a 29 [year old] ...at 38[weeks]5[days] who presents to [labor and delivery] with [complaint of] chest pain since [6:00 a.m.] with shortness of breath radiating down left arm. Of note, Pt was seen in ED in May for episode of dizziness, palpitations, diagnosed with [Supraventricular tachycardia (SVT) - a condition that causes the heart to beat abnormally fast, usually originating in the upper part of the heart], cardioverted [medical procedure that restores a normal heart rhythm when it’s abnormally fast or irregular], placed on diltiazem [a class of medications called calcium-channel blockers. It works by relaxing the blood vessels so the heart does not have to pump as hard. Diltiazem also increases the supply of blood and oxygen to the heart] 60 [milligram (mg)] [twice a day] per cardiology note. Pt[8] states diltiazem is [as needed], took 2 doses today. Pt was preeclamptic (a serious blood pressure condition that develops during pregnancy) in prior pregnancy, NOT preeclamptic this pregnancy. Pt prescribed aspirin (medication to treat pain, fever, headache, inflammation and can be used to reduce the risk of heart attack) but states she has not been taking it. Pt did not take aspirin for this chest pain today. Pt endorses swelling of upper and lower extremities today and [shortness of breath] improved when sits up. [No known allergies]. [patient] had no OB complaints ...Assessment.29[year old], ...38[weeks] 5[days], with [nonstress test (NST - safe, painless, and noninvasive prenatal screening test that measures the heart rate of a fetus and how it responds to movement)] reactive, reassuring, no decels, Pt [8] 3/50 on cervical exam, not in active labor. Pt to transfer to emergency department for cardiac work up ...Plan ...Transfer to ED for cardiac work up ...” The OBED CN 1 stated the patient was cleared by OB provider and needed cardiac assessment in the main ED. During a concurrent interview and record review on 9/5/24 at 4:20 p.m. with the Emergency Room Director (EDD), Pt 8’s medical record was reviewed for the OBED and ED visit of 7/7/24. The EDD stated she had already reviewed the PCT for the ED visit. The EDD stated she had “no words “ and stated she was unable to tell what happened to the patient. The EDD stated patient was assigned ESI of 2 and was experiencing active chest pain and should have been monitored closely in ED. The EDD stated Pt 8 was placed in waiting room and should have been assessed for vitals at minimum every two hours as per policy and national standards. The EDD validated the medical record indicated Pt 8’s last known contact was at 11:41 p.m. on 7/7/24 and it was unacceptable that no one went to assess the patient until 8:06 a.m. on 7/8/24. The EDD validated the medical record reflected the ED physician was not assigned to the patient until 6:15 a.m., a time lapse of seven hours and thirty-eight minutes after triage. The EDD stated that was long delay for someone with active chest pain and shortness of breath and was not acceptable. The EDD stated the EKG was reviewed by provider at 11:00 p.m. a time lapse of more than hour and half after arriving in the OBED and more than 30 minutes after arrival to ED. The EDD stated the ED triage nurse did start the chest pain protocol, but the medical record did not reflect that the patient was evaluated by the physician or if any results were reviewed by the provider. The EDD validated Pt 8’s medical record did not reflect an attempt from the provider to the call the patient’s phone number or followed up with patient regarding her low lab values. The EDD stated she would have expected the provider or charge nurse to call and do welfare check on a pregnant patient that eloped from ED with abnormal lab values and active chest pain. During a concurrent interview and record review on 9/10/24 at 7:32 a.m. with the Registered Nurse (RN) 8 and ED practice coordinator (PC) 1 Pt 8’s medical record was reviewed for the OBED and ED visit of 7/7/24. RN 8 stated he had already reviewed the medical record for Pt 8. RN 8 stated he was assigned as Mobile Intensive Care Nurse (MICN - registered nurse who has been authorized to provide medical direction to paramedics and other emergency medical care personnel in the pre-hospital setting) on 7/7/24 and was responsible for triaging the patient. RN 8 stated the process for OBED is either they call MICN or Practice Coordinator on shift and inform them that they are bringing a pregnant patient from OBED to the main ED that needs medical evaluation. RN 8 stated the OBED team usually talks to a PC and would bring the pregnant patient to MICN for evaluation. RN 8 stated pregnant patients can either go to MICN desk or Main triage, depending on a patient’s complaint and medical status. RN 8 stated in reviewing his documentation, Pt 8 had history of SVT, not active SVT, however Pt 8 had active chest pain. RN 8 stated he initiated the chest pain protocol. RN 8 stated labs were drawn, and Pt 8 was placed in the main lobby waiting area. RN 8 stated the triage area RN would have been responsible for the patient at that point. RN 8 stated patients of ESI of 2 should have vitals every two hours minimum. RN 8 stated he was unable to comment on why the patient was not assessed as per policy. RN 8 stated it was a long time from 11:41 p.m. to 8:06 a.m. when the staff started to call for Pt 8. RN 8 validated the medical record did not indicate any documentation that reflected staff or provider attempted to call Pt 8 to check on her. PC 1 stated any patient with ESI of 2 should have their vitals assessed at minimum every two hours. PC 1 validated she was unable to find any documentation from staff or provider that an attempt was made to call the patient for welfare check. PC 1 stated she had herself called other patients before for welfare check. PC 1 validated the medical record did not reflect that patient was seen by any ED provider for cardiac issues prior to elopement even though the patient came in with active chest pain as chief complaint. During a review of the facility’s policy and procedure (P&P) titled, “Elopement,” with a revised date of October 2023, the P&P indicated, “ ... Purpose: It is the intention of [hospital name] to provider and maintain safe, healing, and therapeutic environment for all patients. Patient elopements may present a risk to patient and colleague safety ...the following steps should be taken ...The elopement should be charted in the patient’s record; and ...an even report should be filed ...if there are concern that the patient will suffer significant harm without medical treatment, the staff or attending physician/provider should attempt to reach the patient or the patient’s emergency contact to check on the patient ...” During a review of the facility’s policy and procedure (P&P) title, “Emergency Department Arrival (Tirage), Documentation, and Discharge” with a revised date of February 2024, the P&P indicated, “ ... This policy serves to provide guidelines to ensure effective triage, documentation, and safe discharge processes in the care of the Emergency Department patient ... Emergency Severity Index (ESI) Score will be given after initial assessment by a trained triage RN ...Frequency of ongoing assessment/documentation will be based patient acuity, desired responses to interventions, any change in condition, and handoff of care ...ESI Level 2: Document at least every 2 hours or more frequently based on clinical condition ...” 4. During a concurrent interview and record review on 9/6/24 at 10:00 a.m. with Obstetric Emergency Department (OBED) Charge Nurse (CN) 1 and Registered Nurse Manager Consultant (RNMC), Pt 18’s medical record was reviewed for the OBED and Emergency Department (ED) visit date of 6/21/24. The document titled “Patient Care Timeline (PCT)” for the visit date 6/21/24 was reviewed. The PCT indicated Pt 18 arrived in OBED at 5:36 p.m. with the chief complaint of suicidal ideation. Pt 18 was determined to be a high risk after using the [Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment tool that supports suicide risk assessment through a series of simple, plain-language questions] and was then placed on 1:1 observation. Pt 18 was transferred to main emergency room at 7:05 p.m. MSE was stated at 7:16 p.m. and Pt 18 was medically cleared at 7:17 p.m. Pt 18 was placed on Behavioral health hold 1799 (a medical hold in California that allows licensed healthcare providers to detain a patient for up to 24 hours. A 1799 hold can be used when a patient is believed to be a danger to themselves or others, or if they are gravely disabled and cannot safely be released) at 7:17 p.m. and social worker consult was ordered. The PCT indicated, “ 7:58 p.m. ...ED Notes ...Patient present as a direct transfer from [hospital name] OB for suicidal ideation. Currently 21 weeks pregnant. Per patient she has been having ongoing suicidal thoughts during this pregnancy with intent of using a gun to shoot herself. Patient endorses prior history of psych issues and takes [Aripiprazole (medication that helps treat several kinds of mental health conditions)], [Escitalopram (medication to treat certain mental/mood disorders like depression and anxiety)], [Buspirone (medication to treat anxiety)]. The PCT indicated on 6/22/24 at 8:42 p.m. Pt 8 ED disposition was set to Transfer to another facility and at 10:59 p.m. Pt 8 was transferred out to [facility Name] for higher level of care, psych evaluation and treatment. CN 1 stated record reflect that social worker saw the patient and patient was placed on 5150 hold and was transferred out for psych eval and treatment. she was unable to find any documented fetal heart rate (FHR) assessment in the Pt 18’s medical record during the entire ED visit. CN 1 stated Pt 18 was 21 weeks pregnant and arrived directly in Obstetrics Emergency Department (OBED - provides timely and efficient emergency care to pregnant patients presenting with unscheduled medical needs) and should have had a documented assessment for FHR. CN 1 stated she was able to find doppler (a noninvasive test that utilizes sound to measure the blood flow through blood vessel ) documented but no FHR. CN 1 stated FHR are required to safely triage the patient and are required to be documented as part of OB Medical screening exam. CN 1 stated it was not clear whether the FHR was not found or not documented. CN 1 stated if the inability to detect fetal heart rate requires immediate intervention and would have been a critical finding. CN 1 stated FHR was required to appropriately triage the patient and triage nurse would need FHR to appropriately use Maternal Fetal Triage Index scoring. During a concurrent interview and record review on 9/6/24 at 10:15 a.m. with OBED CN 1 and RNMC, Pt 18’s medical record was reviewed for the OBED & Emergency Department (ED) visit date of 6/21/24. The document titled “Obstetrical (OB) Triage Note” dated 6/21/24 was reviewed. The document “OB Triage Note” indicated, “ ...[Pt 18] is a 27 [year old] ...with an Estimated Date of Deliver of 11/1/2024 ...who is now 21-week 0-day gestation ....Triage course ...pt referred by [physician name] office because she complains of being suicidal. She states she has mental health issues and has had previous episode of being suicidal. Nurse supervisor was contacted, and plan was made to take transport the pt to regular ED for further evaluation since she does not have obstetrics problem ...Disposition. Transfer to another facility ...” During a concurrent interview and record review on 9/10/24 at 10:15 a.m. with OBED CN 1, RNMC, and Interim-Director Infant and Women Services (RND), the CN1 stated she had reviewed the medical record again for Pt 18 and unable to find any documented FHR. CN 1 stated FHR were required for appropriate MSE. CN 1 stated under the MFTI assessment electronic medical record (EMR) does not have hard stop for FHR. CN 1 stated the EMR will still let you move forward with MFTI without a FHR. The RNMC and RND both stated it was their expectation that as part of triage assessment and hospital policy that qualified medical screening examination assessment includes FHR assessment and documented in EMR. During a phone interview on 9/23/24 at 8:15 a.m. with Pt 18, Pt 18 stated she is felling much better now and the baby is over eight months gestational age. Pt 18 stated both her and her baby is doing well. Pt 18 stated she follows with her OB-GYN [physician’s name office] and do not have anything she would like to discuss further on the phone. During a review of the facility’s policy and procedure titled, “Scope of Services for the Obstetrical Emergency Department,” with a review date of April 2020, the P&P indicated, “ ...Purpose: To define the scope of services provided by the OB Emergency Department of Saint Agnes medical Center ...OB-ED ...designated for evaluation of obstetrical patients 20 weeks gestation and greater ...The OB ED delivers care to pregnant patients of all ages, 20 weeks gestation or greater , who are experiencing uncomplicated emergency and/or remedial problems associated with pregnancy ...OB ED shall fulfill the following responsibilities ...Assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay to inquire about the payment status...Mechanism to identify Patient Needs: ...Patient Assessment ...Maternal and Fetal assessments and findings will be documented accordingly in [Electronic Medical Record].” During a review of the facility’s policy and procedure titled, “CARE OF THE OBSTETRICAL EMERGENCY DEPARTMETN PATIENT,” with a review date of April 2020, the P&P indicated, “ ...Purpose: To provide standardized guidelines where by patients presenting to the Obstetrical Emergency Department (OB ED) are treated based upon acuity system to expedite care for patients ...A qualified Obstetrical triage nurse will briefly and accurately evaluate all patients based upon urgency of complaints or time of arrival if equal urgency, including but not limited to chief complaint and clinical status, using the Maternal Fetal Triage Index (MFTI) ...Continuous fetal monitoring will be initiated as applicable for pregnancy gestations 24 weeks or greater, and a Non-Stress Test (NST) conducted to evaluate fetal heart rate, variability, presence of periodic and /or episodic patterns, fetal movement and presence of contractions: KEYPOINT: A Doppler may be used to evaluate fetal heart rate and rhythm for pregnancy gestation less than 24 weeks. A minimum of 30-60 seconds should be auscultated to determine rate ....A complete nursing assessment shall include ...fetal status ...The assessment shall be documented promptly in the EHR ...” During a review of the facility’s policy and procedure titled, “Standardize procedure: OB Medical Screening Examination,” with a review date of June 2024, the P&P indicated, “ ...Initiate a Medical Screening Examination (MSE) on pregnant patients of 20 weeks gestation or greater to determine if an Emergency Medical Condition (EMC) related to the pregnancy exists ...Patient condition: Pregnant patient 20 weeks gestation or greater with a pregnancy related condition or complaint ...Special circumstance: Notify the physician immediately and consider establishing IV access for any of the following conditions...inability to detect fetal heart rate ...Medical Screening Examination ...For the OB patient this includes but is not limited to labor. Obstetrical medical screening examinations are performed by a physician or qualified Medical Screening Examination Nurse ... Qualified medical screening examination nurse to provide the following assessment ...Fetal heart rate: baseline, accelerations, decelerations, variability (minimum of 20- minute strip) ...Consideration for discharge ...Physician has physically evlauted the patient and certified patient is not in active labor and stable for discharge ...Reactive Non Stress Test or fetal tracing appropriate for gestational age ...””

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 49230 Based on interview and record review, the hospital failed to provide stabilizing treatment within their capabilities for one of 21 patients, (Patient 3), with emergency medical conditions when Pt 3 was brought in by ambulance (BIBA) on 8/14/24 to the hospital ED with altered mental status, history of insulin dependent diabetes, high blood glucose and high blood pressure. A medical screening exam was conducted by a ED physician, and Pt 3 was discharged with high blood glucose and high potassium and the admission altered mental status had not improved. These failures of not stabilizing Pt 3 resulted in Pt 3 returning to the ED by ambulance within eight hours of discharge with altered mental status, high blood glucose and diabetic ketoacidosis and the need for a higher level of care, in an inpatient unit. Findings: During a review of Pt 3’s “Ambulance record” dated 8/14/24, the “Ambulance record” indicated, “ ...Arrived on scene to find the patient sitting in the kitchen with her family. The patient’s [chief complaint] is [Altered Mental Status (AMS)], last seen normal is [7:30 p.m.] yesterday. The patient’s son states that the patient has [history] of type 1 diabetes (a chronic condition in which body makes little or no insulin (insulin is a hormone the body uses to allow sugar [glucose] to enter cells to produce energy) and her [blood glucose level] was high when they checked [patient on arrival]. The patient takes insulin; however, it is not known if she took it today. The Patient’s last meal was a cup of noodles last night and today she has not eaten anything. The patient has been taking several naps today and complains of weakness and confusion. The patient was transported to the hospital last week for a similar complaint. Upon making contact with the patient, she is a Glasgow Coma Scale (GCS - is a clinical scale used to reliably measure a person’s level of consciousness after a brain injury. The GCS assesses a person based on their ability to perform eye movements, speak, and move their body. A person’s GCS score can range from 3 (completely unresponsive) to 15 (responsive))14 [patient baseline GCS 15]. [Blood Glucose Level (BGL)] reads high, and she is also hypertensive, all other vitals [with in normal limits]. The patient is unable to state this year, day, or month ...” During a record review Pt 3’s medical record was reviewed for the Emergency Department (ED) visit for 8/14/24 and 8/15/24. The document titled “[Hospital Name] Emergency Department Note” dated 8/14/24 was reviewed and indicated, “ ...[Pt 3 was] a 75-year-old female [with past medical history of] hypertension (high blood pressure) and type 1 diabetes (a chronic condition in which the hormone insulin is not produced in sufficient quantity to regulate blood glucose) was BIBA with altered mental status. Per [Emergency Medical Services], patient was last seen normal at [7:30 p.m.]. States family reports pt was lethargic and confused. Blood sugar in route was 600. [Blood pressure] systolic in 200s. Pt’s GCS 15 at baseline. Per patient, she did not take insulin today. History is limited secondary to AMS ...physical exam...confused ...ED course: Patient evaluated for hyperglycemia (high blood sugar) and non-compliance. She received 3 [liters] of normal saline and insulin. She was re-evaluated much improved blood sugar under 400 upon discharge. She was counseled at length regarding taking her medications ...Hospitalization [inpatient or Observation] was considered and discussed with the patient. After discussion it was decided (and the patient agreed) that: the patient was stable for discharge with close follow up ...ED Disposition: Discharge ...” During a concurrent interview and record review on 9/5/24 at 10:10 a.m. with the Emergency Department Director (EDD) and Quality Analyst (QA) 1, Pt 3’s medical record was reviewed for the ED visit for 8/14/24 and 8/15/24. The document titled “Patient Care Timeline (PCT)” for the visit dated 8/14/24 was reviewed and indicated Pt 3 arrived to ED on 8/14/24 at 8:10 p.m. with a chief complaint of AMS. GCS on arrival to ED at 8:10 p.m. was 14. Initial Vitals on 8/14/24 at 8:10 p.m. indicated Heart Rate (HR) 71 beats per minute (BPM) (normal 60 -100 bpm), Blood Pressure (BP) 204/69 millimeters of mercury (mmHg- Unit of measurement)(normal 120/80), oxygen saturation 97 % (normal 95% to 100%) on 2 liters per minute (lpm-Unit of measurement) oxygen. Pt 3 was assigned emergency severity index (ESI) level 2 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious). Lab results at 8:49 p.m. indicated glucose level of 641 Milligrams per deciliter (mg/dL - Unit of measurement) (normal 70-105), Potassium (measurement of electrolyte in blood) 5.3 millimoles per liter (mmol/L- Unit of measurement)(normal 3.5- 4.9), Sodium (measure the level of electrolyte) 132 mmol/L, TCO2 Venous POCT(measurement of carbon dioxide) 22 mmol/L (normal 23-29). Lab results on 8/14/24 at 9:02 p.m. indicate blood glucose level of 655 mg/dL. Pt 3 lab results at 9:02 p.m. indicated pH Venous (measurement that tells how acidic or basic something is) 7.28 (normal 7.31 - 7.41), potassium 5.4 mmol/L (normal 3.5 to 4.9) and sodium level 134 mmol/L (138-146). Lab results on 8/14/24 at 9:27 p.m. indicated hemoglobin (Hb -protein in red blood cells that carries oxygen from your lungs to the rest of your body) 11.6 grams per deciliter (g/dl - Unit of measurement)(normal Hb 12-16). Lab results on 8/14/24 at 9:32 p.m. indicated blood glucose of 575. Pt 3’s vitals were rechecked on 8/14/24 at 10:09 p.m. and record indicated BP of 174/50. Pt 3’s disposition set to discharge on 8/14/24 at 11:58 p.m. Pt 3’s blood glucose level on 8/15/24 at 12:21 a.m. indicated 459 mg/dL. Pt.3’s blood glucose level on 8/15/24 at 1:38 a.m. indicated 298 mg/dL. The “Patient Care Timeline” indicated, “ ...Departure condition: Stable ...Temp: 36.8 ...Heart Rate 73 ...BP 160/68 ...Patient observation: pt is discharged. GCS 14 ...picked up by son ...”. Pt 3 was discharged at 1:52 a.m. The EDD stated Pt 3 was discharged in five hours and forty-nine minutes. The EDD stated she was unable to find any documentation regarding high potassium level or low sodium level. The EDD stated Pt 3 received 3-liter normal saline bolus, 30 units of insulin and 20 mg of hydralazine (medication to treat high blood pressure) and was discharged. The EDD stated Pt 3’s GCS was 14 documented at the time of discharge. The EDD stated she was not too concerned with vitals, BP 160/68 at the time of discharge. The EDD stated she was not able to comment if the BG of 298 mg/dL at the time of discharge was acceptable and would have to defer to the provider and his assessment. The EDD stated the ED provider note indicated hospitalization was discussed and patient agreed. The ED physician note also stated pt was counseled about medications. The EDD validated the last documented GCS before discharge was 14 and stated a patient with GCS 14, pt would be confused and it would be hard for patient to understand and participate in decision making. During a concurrent interview and record review on 9/5/24 at 10:20 a.m. with the EDD Pt 3’s “After Visit Summary (AVS)” for the ED visit dated 8/14/24 was reviewed. The EDD stated the AVS did not have the discharge instructions. The EDD stated the record does not reflect that Pt 3 received instructions regarding hyperglycemia, medication and follow up treatments upon discharge. The EDD stated she would have expected to see education regarding discharge diagnosis, information regarding when and where to follow up and new medications if patient received any. The EDD stated without the documentation, Pt 3’s discharge was a “poor discharge and medical decision making was not clear” The EDD stated record reflects that patient had abnormal labs, was a GCS 14 and did not receive any discharge instructions at the time of the discharge. The EDD stated this visit of Pt 3’s would be reviewed by the facility for unsafe discharge as the patient returned with hyperglycemia. The EDD stated it was her expectation that patient critical labs get addressed and patient receive appropriate discharge instructions and education prior to discharge. The EDD stated, “it probably would have been best to keep the patient for additional time if her GCS was 14 to ensure she was back to baseline “. During a review of Pt 3’s “Ambulance record” dated 8/15/24, the “Ambulance record” indicated, “ ... 75 [year old] female sitting in a chair at home in mild distress. GCS 14. Pt baseline GCS 15. Per Pt son pt was seen and treated at [hospital name] yesterday with the same complaint. Pt [history]with hyperglycemia ...Pt son stated that the pt was still disoriented with BG in the 300’s when she was discharged from the ED around [2:00 a.m.]this morning. Pt’s son stated he left the Pt sleep. When the Pt woke Pt’s son stated pt was more disoriented. Pt’s son checked Pt’s BG and it read 429. Pt’s BG was 427 for EMS ....Pt noted as hypertensive ...Pt transported to [hospital name] ...” During a record review Pt 3’s medical record was reviewed for the ED visit for 8/14/24 and 8/15/24. The document titled “Patient Care Timeline (PCT” and “[Hospital Name] Emergency Department Note” dated 8/15/24 was reviewed. The documented “Patient Care Timeline” indicated, Pt 3 was brought back to the ED on 8/15/24 at 9:23 a.m.(seven hours and thirty minutes after discharge) by ambulance with the chief complaint of AMS, GCS of 14 and upon arrival ESI of 2 was assigned. Vitals on 8/15/24 at 9:26 a.m. indicated HR 77 bpm (normal 60-100), Temp 36.7, BP 193/72 mmHg (normal 120/80). Labs indicated blood glucose level was 402 mg/dL on 8/15/24 at 10:36 a.m. Lab results on 8/15/24 at 11:11 a.m. indicated beta hydroxybutyrate (test to detect ketones to diagnose and monitor diabetic ketoacidosis ) at 3.20 mmol/l (normal 0.02-0. 27). amylase level on 8/15/24 at 11:11 a.m. indicated amylase (an enzyme that helps digest carbohydrates) 20 unit/liter(unit/L- Unit of measurement) (normal 29-103). On 8/15/24 at 11:21a.m. Pt 3 disposition was set to admit to inpatient and patient was admitted at 11:56 a.m. The “[Hospital Name] Emergency Department Note” dated 8/15/24 indicated, “ ...Patient presents with increased generalized weakness. She has noted to be persistently hyperglycemic with signs of early diabetic ketoacidosis and mild confusion and dehydration. She was started on routine therapy will be admitted to the hospital for further management.... Pt requires admission at this time. Unable to counsel patient secondary to AMS ...”. The PCT indicated patient was admitted to Inpatient unit for blood glucose management. During a concurrent interview and record review on 9/9/24 at 3:20 p.m. with the Emergency Department Medical Director (EDMD) and Emergency Department Manager (EDM), Pt 3’s medical record was reviewed for the ED visit for date 8/14/24 and 8/15/24. The EDMD stated he was the medical director for the ED and was also the ED provider for the patient on the visit dated 8/14/24. The EDMD stated patient 3 was treated appropriately on 8/14/24, and all vitals were stable at discharge. The EDMD stated Patient 3 was dehydrated and was given a bolus. The EDMD stated he identified that discharge instructions could be better and reeducation to all ED providers had been started. The EDMD stated he does not recall the patient or the case specifically but believes that patient was not confused based on his note as he documented “It was considered to admit the patient, but he felt with shared decision making she can go home”. The EDMD stated he wrote patient agreed, back to base line and it would have been based on his assessment. The EDMD stated it was not a pre template note therefore he believes everything was done appropriately. The EDMD stated he reviewed Pt 3’s medical record for revisit and does not feel Pt 3 was in true DKA when the patient returned to ED. During a review of the facility’s policy and procedure (P&P) titled, “EMERGENCY DEPARTMENT ARRIVAL (TRIAGE), DOCUMENTATION, AND DISCHARGE” with a reviewed date of February 2024, the P&P indicated, “ ...Discharge ...All patient discharged from the Emergency Department will receive appropriate discharge instructions including information regarding any necessary follow up care and instructions on medication, devices and diagnosis ...The nurse will involve other resources deemed necessary to facilitate a safe discharge ...” During a review of the facility’s policy and procedure (P&P) titled, “Emergency Medical Treatment and Labor Act (EMTALA) Compliance”, with a reviewed date of June 2024, the P&P indicated, “ ... Policy Statement ...Any individuals who comes to [Hospital Name] (the “Hospital”) seeking an examination and treatment of potential emergency medical condition will receive a screening examination to determine the existence of any emergency medical condition, necessary stabilizing treatment for any emergency medical condition, and if necessary, an appropriate transfer to another medical facility, without regard to the individual’s ability to pay or method of payment ...Treatment of Individual with an [emergency medical condition]exists, the Hospital shall: provide further examination and treatment, within the capability of the Hospital, until the individual’s condition is stabilized; or provide for an appropriate transfer of an un-stabilized individual to another medical facility as set forth in this policy ...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 42321 Based on observation, interview, record review, the facility failed to have an effective governing body legally responsible for the conduct of the hospital when: 1. The hospital failed to ensure that a hospital wide quality assurance performance improvement program (QAPI-data driven program that focuses on systems of care, outcomes of care, and quality of life) was implemented when the hospital did not identify and complete a root cause analysis (systematic process for identifying problems or events and an approach for responding to them) when P1 1’s medication reconciliation (the process of identifying the most accurate list of all medications that a patient is taking and comparing that list against a physician’s admission, transfer, and/or discharge orders to avoid medication errors) was not completed for Pt 1 and resulted in Pt 1 not receiving medication needed to control atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), which led to Pt 1 having AFib with rapid ventricular response (RVR- occurs when the rapid contractions of the atria cause the ventricles [the lower chambers of the heart] beat too fast) which led to Pt 1’s transfer to a higher level of care, prolonged her hospital stay and placed her at increased risk for stroke. (Refer to A-283) 2. The GB did not ensure the hospital had an organized medical staff responsible for the quality of medical care provided to patients when hospital failed to follow the bylaws, rules and regulations, and policies of the medical staff for privileging (authorizations granted to healthcare professionals, such as physicians or surgeons, by a hospital’s governing board to practice medicine and perform specific procedures within the hospital) Allied Health Professional (AHP, Nurse Practitioner [NP], Physician Assistant [PA], or Certified Registered Nurse Anesthetist [CRNA]) staff when 16 of 20 sampled AHPs (NP 1, PA 1, CRNA 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,) did not have evidence they completed the required concurrent proctoring (objective evaluation of a provider’s clinical competence by someone) prior to performing procedures independently, and the hospital did not have a process in place to track compliance with the proctoring requirements. (Refer to A339) Because of the potential for serious harm to patients who received care from an Allied Health Professional (AHP - Nurse Practitioner (NP), Physician Assistant (PA), or Certified Registered Nurse Anesthetist (CRNA- a registered nurse trained to provide anesthesia [medical intervention that prevents patients from feeling pain during procedure and surgery]) who were not tracked and monitored for required proctoring by medical staff office and may not have been qualified to perform services to patients and because CRNA 1, CRNA 2, CRNA 3, CRNA 4, PA 1 and NP 1 performed services on patients without first providing proof of concurrent proctoring to ensure qualified and met privileging requirements, an Immediate Jeopardy (IJ a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 7/31/24 at 11:25 a.m. with the Chief Medical Officer (CMO), Chief Nursing Officer (CNO), President and Market Leader (PML), Director of Clinical Quality Improvement (DQ), and the Manager of Quality Improvement (QIM). The IJ (immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 7/31/24 at 2:51 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Two) on 8/1/24 at 8:14 a.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Three) on 8/1/24 at 1:32 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Four) on 8/1/24 at 3:54 p.m. it was reviewed and accepted at 4:57 p.m. with the DQ. On 8/1/24 and 8/2/24 the survey team validated that staff were able to look up AHPs to see what privileges they had and see if concurrent proctoring was still needed, observations done in surgical department to confirm concurrent proctoring was being done, and education as to why this was important was interviewed to. Review of concurrent proctoring forms and surgery schedule for 8/1/24 and 8/2/24 indicated there was overlap seen of the same proctor being used and the DQ, CMO and MSD confirmed the proctor was only in the room during the most important times and not the whole surgery. The DQ, CMO, and MSD confirmed this was the process being used and stated the Medical Staff Bylaws and policies were being updated and felt this was safe care their patients. They provided a written statement signed by the CMO and the President of Medical Staff (MSP) indicating above, and MSD stated she would add a statement at the bottom of the proctor forms that the proctor must check attesting that they were present during the most important times of the cases. On 8/2/24 at 3 p.m. while onsite the IJ was removed with CMO, DQ, QIM and MSD. The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner for staff and patients.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 42321 Based on interview and record review, the hospital failed to ensure that a hospital wide quality assurance performance improvement program (QAPI-data driven program that focuses on systems of care, outcomes of care, and quality of life) was implemented when the hospital did not identify and complete a root cause analysis (systematic process for identifying problems or events and an approach for responding to them) when P1 1’s medication reconciliation (the process of identifying the most accurate list of all medications that a patient is taking and comparing that list against a physician’s admission, transfer, and/or discharge orders to avoid medication errors) was not completed for Pt 1 and resulted in Pt 1 not receiving medication needed to control atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), which led to Pt 1 having AFib with rapid ventricular response (RVR- occurs when the rapid contractions of the atria cause the ventricles [the lower chambers of the heart] beat too fast) which led to Pt 1’s transfer to a higher level of care, prolonged her hospital stay and placed her at increased risk for stroke. (Refer to A-283) The cumulative effect of this systemic problem resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe environment.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 37529 Based on interview and record review the hospital failed to have an organized medical staff responsible for the quality of medical care provided to patients when hospital failed to follow the bylaws, rules and regulations, and policies of the medical staff for privileging (authorizations granted to healthcare professionals, such as physicians or surgeons, by a hospital’s governing board to practice medicine and perform specific procedures within the hospital) Allied Health Professional (AHP, Nurse Practitioner [NP], Physician Assistant [PA], or Certified Registered Nurse Anesthetist [CRNA]) staff when 16 of 20 sampled AHPs (NP 1, PA 1, CRNA 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,) did not have evidence they completed the required concurrent proctoring (objective evaluation of a provider’s clinical competence by someone) prior to performing procedures independently, and the hospital did not have a process in place to track compliance with the proctoring requirements. (Refer to A339) Because of the potential for serious harm to patients who received care from an Allied Health Professional (AHP - Nurse Practitioner (NP), Physician Assistant (PA), or Certified Registered Nurse Anesthetist (CRNA- a registered nurse trained to provide anesthesia [medical intervention that prevents patients from feeling pain during procedure and surgery]) who were not tracked and monitored for required proctoring by medical staff office and may not have been qualified to perform services to patients and because CRNA 1, CRNA 2, CRNA 3, CRNA 4, PA 1 and NP 1 performed services on patients without first providing proof of concurrent proctoring to ensure qualified and met privileging requirements, an Immediate Jeopardy (IJ a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 7/31/24 at 11:25 a.m. with the Chief Medical Officer (CMO), Chief Nursing Officer (CNO), President and Market Leader (PML), Director of Clinical Quality Improvement (DQ), and the Manager of Quality Improvement (QIM). The IJ (immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 7/31/24 at 2:51 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Two) on 8/1/24 at 8:14 a.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Three) on 8/1/24 at 1:32 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Four) on 8/1/24 at 3:54 p.m. it was reviewed and accepted at 4:57 p.m. with the DQ. On 8/1/24 and 8/2/24 the survey team validated that staff were able to look up AHPs to see what privileges they had and see if concurrent proctoring was still needed, observations done in surgical department to confirm concurrent proctoring was being done, and education as to why this was important was interviewed to. Review of concurrent proctoring forms and surgery schedule for 8/1/24 and 8/2/24 indicated there was overlap seen of the same proctor being used and the DQ, CMO and MSD confirmed the proctor was only in the room during the most important times and not the whole surgery. The DQ, CMO, and MSD confirmed this was the process being used and stated the Medical Staff Bylaws and policies were being updated and felt this was safe care their patients. They provided a written statement signed by the CMO and the President of Medical Staff (MSP) indicating above, and MSD stated she would add a statement at the bottom of the proctor forms that the proctor must check attesting that they were present during the most important times of the cases. On 8/2/24 at 3 p.m. while onsite the IJ was removed with CMO, DQ, QIM and MSD. The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 49538 Based on interviews and record review, the hospital failed to have a well-organized and effective nursing service when: 1. Licensed nurses did not have blood glucose (sugar in the blood) monitoring completed for one of one patient (Pt 22) according to the hospital’s policy and procedure (P&P) titled, “Hyperglycemia/Hypoglycemia Treatment.” (Refer to A398 finding 1). 2. Licensed nurses did not have baseline vital signs (blood pressure, heart rate/rhythm, respiratory rate, oxygen saturation) and pain assessment completed prior to a procedure for one of four patient (Pt 23) according to the hospital’s P&P titled, “Sedation/Analgesia, Moderate.” (Refer to A398 finding 2). 3. Licensed nurses did not provide one of two patient (Pt 23) discharge instructions in Spanish according to the hospital’s P&P titled, “Discharge Planning.” (Refer to A398 finding 3). 4. Licensed nurses did not complete an assessment in the initial recovery period for two of four patients (Pt 24 and Pt 25) according to the hospital’s P&P titled, “Documentation, Endoscopy.” (Refer to A398 finding 4). 5. Licensed nurses did not assess and document wound incision assessments when transferred to postpartum (mother-baby unit) for two of two patients (Pt 27 and Pt 28) per the hospital’s P&P titled, “Postpartum Care.” (Refer to A398 finding 5). 6. Licensed nurses failed to use an interpreter when signing a consent form for a cesarean section for one of one patient (Pt 27) according to the hospital’s P&P titled, “Informed Consent/Consent Forms.” (Refer to A398 finding 6). 7. Licensed nurses failed to follow their P&P to reduce the risk of skin breakdown when Pt 18 did not have a documented pressure relieving interventions every two hours on multiple shifts between 5/30/24 to 6/10/24 for the left heel in accordance with the facility policy. (Refer to A398 finding 7). The cumulative effect of these deficient practices resulted in the facility’s inability to provide care in a safe and effective manner.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 49230 Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of Hospital Acquired Infections (HAI’s) and other infectious diseases, when: 1.Hot lab room (rooms in nuclear medicine hospitals that have been specially designed to deliver, store, and prepare radioactive materials) walls had rough surface with black stains and paint chipped above and around the radiopharmaceuticals (radioactive agents that are used to help diagnose certain medical problems, only small amounts are given to the patient) storage. The Hot lab patient nourishment refrigerator inside flooring had brown deposits, yellow stains and was stocked with expired boxes of the orange juices. (Refer to A-0750 finding 1) 2.Used Transesophageal echocardiogram (TEE) probes (A thin, flexible tube-like instrument with a probe like a microphone which sends out ultrasonic sound waves used to look at tissues inside the body, usually done by inserting a probe with a transducer down the esophagus) were being cleaned in a ultrasound (sound waves to make pictures of organs, tissues, and other structures inside your body)/ Electro Cardio Gram - (ECG a test to record the electrical signals in the heart area) testing room in between patients, without the room being clean in between scopes cleaning and the next patient testing. (Refer to A-0750 finding 2) 3.Cardiovascular Operating Room (CVOR) satellite pharmacy (decentralized operating unit which has similar function with the central inpatient pharmacy) flooring had a hole with chunk of floor missing inside the sterile compounding (custom made -pharmaceutical preparation) area. The hole was approximately one inch deep and about two inches wide and appear to have dust particles in the hole. The flooring could not be disinfected in accordance with professional standards and had the potential to allow bacteria to harbor in the cracked and chipped surfaces and lead to patient infection. (Refer to A-0750 finding 3) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure staff competency in infection control principles and practices and the provision of quality patient care in a safe and sanitary environment.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 42321 Based on observation, interview and record review, the hospital failed to provide a well-organized surgical service in accordance with acceptable standards of practice when: 1. The complete expiration date of a titanium device was not read off prior to implantation surgery and resulted in an expired device being placed in Pt 11. (Refer to A-0951 finding 1) 2. Expired suture was available for use in the Operating Room (OR) and used on Pt 10 and the Surgeon elected not to remove it. (Refer to A-0951 finding 2) 3. Four of four surgical patients (Pt 43, Pt 44, Pt 45, and Pt 46) Operating Room Report (OP Reports) did not include the names of all staff in the room, nor did it include the in and out times of the anesthesia provider. (Refer to A-0951 finding 3) 4. A blue cauterization cart was used in the OR that had chipped paint and a reddish-brown substance that could be removed. (Refer to A-0951 finding 4) 5. An expired [brand name] certified airway exchange catheter (thin tube used in certain surgeries and medical procedures) was on the Anesthesia cart in the Obstetrics (OB) OR was found and had the potential to be used. (Refer to A-0951 finding 5) 6. Surgical/Procedural staff were seen wearing booties outside of procedural areas. (Refer to A-0951 finding 6) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 49538 Based on interview and record review, the facility failed to ensure care was provided in a safe setting for three of five sampled patients (Pt 40, Pt 41 and Pt 42) when; 1. One of one patient (Pt 40) did not have physician order for violent restraint renewed every four hours in accordance with hospital policies and procedures (P&P). This failure had the potential for unnecessary and unsafe use of restraints in violation of Pt 40’s rights. 2. Two of two patients (Pt 40 and Pt 41) on restraints did not have restraint assessments completed in accordance with hospital policies and procedures (P&P). This failure had the potential for Pt 40 and Pt 41 to have injury from restraints. 3. Two of two patients (Pt 41 and Pt 42) had no physician order for violent restraints in accordance with hospital policies and procedures (P&P). This failure had the potential for Pt 41 and Pt 42 to have the wrong type of restraint and monitoring. Findings: 1. During a review of Pt 40’s “History and Physical (H&P),” dated 7/9/24, the H&P indicated, “ ...Patient is a 23 [year old] male with a past medical history of alcohol abuse ... Patient is aggressive and violent right now ...” During a concurrent interview and record review on 7/30/24 at 3:12 p.m. with Manager (MG) 4, Pt 40’s “Physician Orders (PO),” dated 7/9/24 and “Flowsheets, Restraints Violent (FRV),” dated 7/9/24 were reviewed. The PO indicated, “ ...Restraints violent or self-destructive adult ... Ordering user: [Name of physician] 07/09/24 [8:27 a.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [8:28 a.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ...” MG 4 stated, Pt 40’s PO for violent restraints expired four hours after the start of the order (at 12:27 p.m.). The PO indicated, “ ...Restraints violent or self-destructive adult ...Ordering user: [Name of RN] 07/09/24 [5 p.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [12:28 p.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ...” MG 4 stated, the next physician orders entered for violent restraint was placed on 7/9/24 at 5 p.m. (a time lapse of 4 hours and 33 minutes after the previous order expired). The PO indicated, “ ...Restraints violent or self-destructive adult ...Ordering user: [Name of RN] 07/09/24 [5:03 p.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [4:28 p.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ...” MG 4 stated, the physician order for violent restraint expired at 12:27 p.m. and physician order for violent restraint was not renewed before the expiration time. MG 4 stated, there was no documentation a physician saw Pt 40 when the physician order for violent restraints was placed at 5 p.m. (4 hours and 33 minutes after the order expired). MG 4 stated, the FRV on 7/9/24 indicated Pt 40 remained on violent restraints from 12:31 p.m. to 4:39 p.m. and no other restraint documentation was completed after 4:39 p.m. During an interview on 7/31/24 at 9:45 a.m. with MG 4, MG 4 stated the licensed nurse should have received an order from the physician and entered the order before the first order expired. MG 4 stated, the licensed nurse did not following the policy and procedure (P&P). 2. During a review of Pt 40’s “History and Physical (H&P),” dated 7/9/24, the H&P indicated, “ ...Patient is a 23 [year old] male with a past medical history of alcohol abuse ... Patient is aggressive and violent right now ...” During a concurrent interview and record review on 7/30/24 at 3:12 p.m. with Manager (MG) 4, Pt 40’s “Physician Orders (PO),” dated 7/9/24 and “Flowsheets, Restraints Violent (FRV),” dated 7/9/24 were reviewed. The PO indicated, “ ...Restraints violent or self-destructive adult ...Ordering user: [Name of physician] 07/09/24 [8:27 a.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [8:28 a.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ...” MG 4 stated, Pt 40’s PO for violent restraints expired four hours after the start of the order (at 12:27 p.m.). The PO indicated, “ ...Restraints violent or self-destructive adult ...Ordering user: [Name of RN] 07/09/24 [5 p.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [12:28 p.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ...” MG 4 stated, the next physician orders entered for violent restraint was placed on 7/9/24 at 5 p.m. (4 hours and 33 minutes after the previous order expired). The PO indicated, “ ...Restraints violent or self-destructive adult ...Ordering user: [Name of RN] 07/09/24 [5:03 p.m.] ... Frequency: Routine Continuous x 4 hours 07/09/24 [4:28 p.m.] ... Restraint type: Velcro Restraint ... Location: All Extremities ... Restraint reason: Danger to self, Danger to others ...” MG 4 stated, the physician order for violent restraint expired at 12:27 p.m. on 7/9/24 and Pt 40 remained on violent restraints after 12:27 p.m. MG 4 stated, there were no violent restraint assessments completed from 4:39 p.m. to 6 p.m. on 7/9/24. MG 4 stated, there was no documentation when Pt 40’s violent restraints were discontinued. MG 4 stated, Pt 40 was not assessed for readiness to discontinue restraints every hour and Pt 40’s restraints should have been assessed every hour. During a concurrent interview and record review on 7/31/24 at 9:50 a.m. with MG 4, Pt 40’s “Physician Orders (PO),” dated 7/9/24 and 7/10/24, and “Flowsheets, Restraints Non-violent (FRNV),” dated 7/10/24 were reviewed. The PO indicated, “ ...Restraints non-violent or non-self destructive adult ...Ordering user: [Name of RN] 07/09/24 [6:06 p.m.] ... Frequency: Routine Continuous x 24 hours 07/9/24 [6:06 p.m.] ... Restraint type: Soft Restraint ... Location: Right Wrist, Left Wrist ... Restraint reason: Interference with medical treatment ...” The PO indicated, “ ...Restraints non-violent or non-self destructive adult ...Ordering user: [Name of RN] 07/10/24 [5:57 p.m.] ... Frequency: Routine Continuous x 24 hours 07/10/24 [5:58 p.m.] ... Restraint type: Soft Restraint ... Location: Right Wrist, Left Wrist ... Restraint reason: Interference with medical treatment ...” MG 4 stated, there was no documentation the physician saw Pt 40 when the restraint order was renewed on 7/10/24 at 5:57 p.m. MG 4 stated, non-violent restraint assessments were not completed for Pt 40. MG 4 stated Pt 40’s restraints should had been assessed every two hours after 5:57 p.m. until the restraints were discontinued on 7/11/24 at 2:52 a.m. MG 4 stated, non-violent restraint assessments should have been completed every two hours until it was discontinued. During a review of Pt 41’s “History and Physical (H&P),” dated 6/15/24, the H&P indicated, “ ...a 39-year-old male with [past medical history] of depression, bipolar, schizophrenia and multiple personality disorder ...” During a concurrent interview and record review on 7/31/24 at 10:20 a.m. with MG 4, Pt 41’s “Physician Orders (PO),” dated 6/20/24 and “Flowsheets, Restraints Violent (FRV),” dated 6/20/24 were reviewed. The PO indicated, “ ...Restraints violent or self-destructive adult ...Ordering user: [Name of physician] 06/20/24 [8:36 a.m.] ... Frequency: Routine Continuous x 4 hours 06/20/24 [8:36 a.m.] ... Restraint type: Side Rails Up, Velcro Restraint ... Siderail #: 2 ...Location: Right Wrist, Right Ankle, Left Wrist, Left Ankle, All Extremities ... Restraint reason: Danger to self ...” The FRV indicated, “ ... [8:36 a.m.] ... Clinical Justification ...Imminent risk of harm to self ... Restraint Type ...Velcro Restraint [Right] Wrist (V) ...Start ... Velcro Restraint [Left] Wrist (V) ...Start ... Velcro Restraint [Right] Ankle (V) ...Start ... Velcro Restraint [Left] Ankle (V) ...Start ...” MG 4 stated, violent restraint assessments were not completed every 15 minutes after 8:36 a.m. until Pt 41 was discharged at 2:39 p.m. to a psychiatric hospital. MG 4 stated, violent restraint assessments should have been completed every 15 minutes until Pt 41 was discharged. MG 4 stated, she expected licensed nurses to assess and document every 15 minutes when Pt 41 was on violent restraints. MG 4 stated, Pt 41 was not assessed for readiness to discontinue restraints every hour, and Pt 41’s restraints should have been assessed every hour. 3. During a review of Pt 41’s “History and Physical (H&P),” dated 6/15/24, the H&P indicated, “ ...a 39-year-old male with [past medical history] of depression, bipolar, schizophrenia and multiple personality disorder ...” During a concurrent interview and record review on 7/31/24 at 9:57 a.m. with Manager (MG) 4, Pt 41’s “Physician Orders (PO),” dated 6/18/24 and “Flowsheets, Restraints Non-Violent (FRNV),” dated 6/18/24 were reviewed. The PO indicated, “ ...Restraints non-violent or non-self destructive ...Ordering user: [Name of physician] 06/18/24 [1:06 p.m.] ... Frequency: Routine Continuous x 24 hours 06/18/24 [1:07 p.m.] ... Restraint type: Soft Restraint ... Location: Left Ankle, Right Ankle ... Restraint reason: Interference with medical treatment ...” The FRNV indicated, “ ... [1:06 p.m.] ... Clinical Justification ...Removal of equipment; Pulling lines ... Restraint Type (NV) ...Soft Restraint [Right] Wrist (NV) ...Start ... Soft Restraint [Left] Wrist (NV) ...Start ... Soft Restraint [Right] Ankle (NV) ...Start ... Soft Restraint [Left] Ankle (NV) ...Start ...” MG 4 stated, the physician order for restraint was for the right and left ankles and did not include the right and left wrists. MG 4 stated, the right and left wrist restraints should not have been started. During a concurrent interview and record review on 7/31/24 at 10:10 a.m. with MG 4, Pt 41’s “Nursing Note (NN),” dated 6/18/24 at 1:04 p.m. was reviewed. The NN indicated, “ ...Patient threatened to pull out IV, patient became aggressive and tore off his paper scrub top. [Physician] notified and ... called security at bedside ...” MG 4 stated, Pt 41 was aggressive. MG 4 stated, the physician order should have been entered as a violent restraint and not a non-violent restraint. MG 4 stated, a non-violent restraint to Pt 41’s legs was not justified for Pt 41. During a review of Pt 42’s “Progress Note (PN),” dated 7/30/24, the PN indicated, “ ...72 [year old male] with [past medical history] of ... history of [traumatic brain injury-an injury that affects how the brain works], bipolar type 1 disorder [causes extreme mood swings] who presented to [name of hospital] on 6/23/24 due to [altered mental status- a condition marked by an abnormal state of alertness or awareness] ...” During a concurrent interview and record review on 8/1/24 at 9:34 a.m. with Registered Nurse (RN) 2, Pt 42’s “Physician Orders (PO),” dated 8/1/24 and “Flowsheets, Restraints Non-violent (FRNV),” dated 8/1/24 were reviewed. The PO indicated, “ ...Restraints non-violent or non-self destructive ...Ordering user: [Name of Nurse Practitioner] 08/01/24 [2:08 a.m.] ... Frequency: Routine Continuous x 24 hours 08/01/24 [2:09 a.m.] ... Restraint type: Soft Restraint ... Location: Right Wrist, Left Wrist, Right Ankle, Left Ankle ... Restraint reason: Interference with medical treatment ...” The FRNV indicated, “ ... [2:09 a.m.] ... Clinical Justification ...Pulling lines; Pulling tubes ...trying to exit bed and swinging legs as if he may kick staff ... Restraint Type (NV) ...Soft Restraint [Right] Wrist (NV) ...Continued ... Soft Restraint [Left] Wrist (NV) ...Continued ... Soft Restraint [Right] Ankle (NV) ...Start ... Soft Restraint [Left] Ankle (NV) ...Start ...” During an interview on 8/1/24 at 12:10 p.m. with Registered Nurse (RN) 2, RN 2 stated, a four-point restraint would be used to make sure a patient does not get out of bed and hurt oneself. RN 2 stated, Pt 42 required a four-point restraint because he was “thrashing and kicks around” due to his confusion. During an interview on 7/30/24 at 12:16 p.m. with the Chief Nursing Officer (CNO), the CNO stated, a patient’s condition determined what type of restraint to use. The CNO stated she expected the correct orders and documentation be completed for restraint use. During a review of the facility’s policy and procedure (P&P) titled, “Restraint/Seclusion for Patient Safety,” revised November 2023, the P&P indicated, “ ...POLICY: ... Restraint for Non-Violent or Non-Self-Destructive Behavior ... Restraint for Violent or Self-Destructive Behavior ...Discontinuation of Restraint ... PURPOSE: To provide guidelines for assessment and utilization of restraint or seclusion to promote healing when a non-violent and a non-destructive patient is unable to follow directions, or when the patient’s behavior is violent or self-destructive and poses an immediate threat to self, staff, or others ... OUTCOME: When a restraint or seclusion is required, it is managed in such a manner that the rights of the patient are promoted, patient dignity is maintained as much as possible, and inherent risks are minimized ... DEFINITIONS: ... Patient Rights: The Patient’s Bill or Rights and Responsibilities includes the patient’s right to receive care in a safe setting, and to be free from restraint or seclusion of any form used as a means of coercion, discipline, convenience, or retaliation by staff ... Restraint: Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of the patient to move their arms, legs, body, or head freely ... Non-Violent Restraints: Restraints used for acute medical or surgical care which supports the physical health and safety of the patient who is non-violent/non-self-destructive ... Violent Restraints: Restraints used to manage the patient’s violent or self-destructive behavior jeopardizing the immediate physical safety of the patient, staff, or others ... Restraint for Non-Violent or Non-Self-Destructive Behavior ... To protect the patient from injury when patient is unable to follow directions (pulling at tubes, dressings, IV lines or other medical equipment that needs to be maintained) ... Licensed Independent Practitioner Evaluation and Order: ... Restraint orders will include reason, type of restraint to be used and time limits. The Licensed Independent Practitioner must see and evaluate the patient before entering a new order each day the patient remains in restraint ... Application of Restraints: ... Restraints must be implemented in accordance with safe, appropriate restraining techniques, hospital policy, state law and manufacturer’s instructions. Restraints are applied by trained staff ... The Licensed Nurse records type of restraint, including time of application and removal in the EHR ... Monitoring: ... The Licensed Nurse assess the physical and physiological condition of the patient to ensure safety, comfort, and readiness for discontinuation of restraint and documents at least every two hours ... Monitoring is documented at least every two hours on the EHR. Assessment includes: ... Type of restraint ...Where restraint is applied on patient’s body ...Skin circulation/restraint site assessment ...Nutrition/hydration ... Hygiene and elimination ...Cognitive/emotional response ...ROM positioning ...Safety ... Restraint or Seclusion for Violent or Self-Destructive Behavior ... To protect the patient when the patient’s behavior, regardless of diagnosis, represents an emergency and jeopardizes the immediate physical safety of the patient, staff member or others ... Licensed Independent Practitioner Evaluation and Order: ... Orders may not exceed these maximum time limits: ... 4 hours for adults 18 years of age or older ... At the end of the time limit, the Licensed Nurse must contact the Licensed Independent Practitioner in person or on the phone and report the assessment and request the order be renewed based on an individualized patient assessment that the behavior still requires restraint or seclusion ... “Monitoring: ...The Licensed Nurse monitors the physical and physiological condition of the patient to ensure safety, comfort, and readiness for discontinuation of restraint or seclusion and documents at least every 60 minutes ... Monitoring occurs and is documented at least every 15 minutes. Monitoring may include, but is not limited to the following: ... Respiratory, circulatory ...Skin integrity ...Vital signs ... Nutrition/hydration ...Range of motion of the extremities ...Hygiene and elimination ...Level of distress and agitation ...Signs of injury associated with the application of restraint or seclusion ... Cognitive functioning ...Mental status ... Discontinuation of Restraint ...(both Non-Violent & Violent) ...The RN documents the patient’s behavior at the time the restraint is discontinued ... APPENDIX B ...Fall Risk ...There is no evidence that falls decrease with the use of restraint. In fact, serious injury rates are higher in facilities that use restraint. Restraint use may contribute to falls through de-conditioning and muscle wasting, sensory deprivation, and exacerbation of underlying gait abnormalities. Some patients have suffered strangulation, impairment of circulation, nerve damage, rhabdomyolysis, and death as a result of being in restraint ...””

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 42321 Based on interview and record review, the hospital failed to develop a program to analyze indicators to improve health outcomes when home medication reconciliation (The process of identifying the most accurate list of all medications that a patient is taking and comparing that list against a physician’s admission, transfer, and/or discharge orders to avoid medication errors) was not being monitored and caused harm to Pt 1, no root cause analysis (systematic process for identifying problems or events and an approach for responding to them) was completed. There was no process in place to review and analyze quality indicators across the hospital. Data was collected in some individual departments, but the information was not reported up to the Quality Department and there was no review and analysis of the data for the Medication Error Reduction Plan (MERP) for medication reconcillation. This failure resulted in the hospital not identifying and acting on critical incidents that could affect all inpatients’ health and well-being.and had the potential to cause harm to any patient whose home medication list was not reconciled and had the potential to cause harm to any patient whose home medication list was not reconciled. (take out inlcude in failure. Findings: During a record review on 7/24/24 at 4 p.m., the hospital’s EHR report of compliance with Admission Medication Reconciliation for 1/1/24 through 7/24/24 was reviewed. The report contained a list of twenty-six patient care areas in the hospital with a month by month percentage of compliance for each area. The report did not give an overall combined compliance rate each month for all areas, but listed the individual months for each area separately. The report indicated for nearly all of the areas, the monthly compliance rate for completion of the admission medication reconciliation (within 24 hours after admission) was between 0% and 50%. The report indicated for 3W (where Pt 1 and Pt 2 were admitted) Station 1, the percentage compliance with admission med rec for January and February 2024 was 0%, March 40%, April 33.3%, May 33.3%, June 33.3%, and for the 3W Station 2, the report indicated January 2024 100%, February 2024 50%, March 40%, April 50%, May 25%, and June 50%. During a record review on 7/25/24 at 11:08 a.m. with the Medication Safety Coordinator (MSP), the MSP stated he was made aware about the report of the compliance rate for admission med rec completion for each area. The MSP stated he did not monitor or review the medication reconciliation compliance in any area of the hospital and did not have reports generated with this information. The MSP stated med rec was not part of the hospital’s Medication Error Reduction Plan (MERP). The MSP stated he wrongly assumed the quality department was monitoring med rec data. During an interview on 7/29/24 at 1:10 p.m., with the Manager of Regulatory and Accreditation (MRA) and the Director of Quality (DQ), the MRA stated medication reconciliation was not a performance improvement project but is going to be one and has shown improvement since a plan was put into place to figure out why it was not getting completed. During an interview on 7/30/24 at 12:16 p.m., with the Chief Nursing Officer (CNO), the CNO stated the nurse or the pharmacy technician put in the patients home medication list, staff were hitting nurse reviewed instead of nurse complete so it can not be restarted by the physician until it is marked nurse completed, education will need to be done for everyone on this. The CNO stated it is important to have the home medication list done for a patient so patients do not miss their medications, duplicates are not put in, and there are no adverse interactions with any medications, “it could cause an adverse outcome to the patient if we do not continue them on their home medications”. During a review of the “Quality Assessment and performance Improvement Plan” for the year of 2024 was reviewed the plan indicated, “PURPOSE the purpose of the Quality Assessment and Performance Improvement (QAPI) Plan for [name of hospital] is to ensure that the governing body, medical staff, and professional service colleagues consistently endeavor to deliver safe, effective, optimal patient care and services in an environment of minimal risk. The plan allows for a systematic, coordinated, continuous, data-driven approach to improving performance, focusing on the processes and mechanisms that address these values ... The plan, established by the Hospital’s Quality committee, with the support and approval of the governing body, has the responsibility for monitoring all aspects of patient care and services (including contracted services), from the time of the patient’s initial participation with any of the services provided by [name of hospital] including diagnosis, treatment, recovery, and discharge activities. These activities are monitored to identify and resolve any breakdowns that may result in suboptimal patient care and safety while striving to continuously improve and facilitate patient outcomes ... ORGANIZATION ... designed to facilitate an effective system of monitoring, assessment, and evaluation of the care and services provided throughout the organization ... the Patient Safety and Quality Committee ... Provides oversight of Hospitals’ patient safety, risk management, and grievance process ... Hospital Departments With the assistance from the Quality Department, each department or service annually selects quality indicators with a focus on indicators that are high risk, high volume, and/or problem prone ...””

“ELIGIBILITY & PROCESS FOR APPT TO MED STAFF CFR(s): 482.22(a) The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope of practice laws, the medical staff may also include other categories of physicians (as listed at §482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body. This Standard is not met as evidenced by: 37529 Based on observation, interview and record review, the hospital failed to follow the bylaws, rules and regulations, and policies of the medical staff for privileging Allied Health Professional (AHP, Nurse Practitioner [NP], Physician Assistant [PA], or Certified Registered Nurse Anesthetist [CRNA]) staff when 16 of 20 sampled AHPs (NP 1, PA 1, CRNA 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14) did not have evidence they completed the required concurrent proctoring (objective evaluation of a provider’s clinical competence by someone) prior to performing procedures independently, and the hospital did not have a process in place to track compliance with the proctoring requirements. This failure resulted in AHPs performing procedures for which they did not have validated current competency, and had the potential to cause patient harm. Because of the potential for serious harm to patients who received care from an Allied Health Professional (AHP - Nurse Practitioner (NP), Physician Assistant (PA), or Certified Registered Nurse Anesthetist (CRNA- a registered nurse trained to provide anesthesia [medical intervention that prevents patients from feeling pain during procedure and surgery]) who were not tracked and monitored for required proctoring by medical staff office and may not have been qualified to perform services to patients and because CRNA 1, CRNA 2, CRNA 3, CRNA 4, PA 1 and NP 1 performed services on patients without first providing proof of concurrent proctoring to ensure qualified and met privileging requirements, an Immediate Jeopardy (IJ a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for A339 42 CFR 482.22(a) on 7/31/24 at 11:25 a.m. with the Chief Medical Officer (CMO), Chief Nursing Officer (CNO), President and Market Leader (PML), Director of Clinical Quality Improvement (DQ), and the Manager of Quality Improvement (QIM). The IJ (immediate Jeopardy) template was provided to the facility. The hospital submitted an IJ Plan of Removal (Version One) on 7/31/24 at 2:51 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Two) on 8/1/24 at 8:14 a.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Three) on 8/1/24 at 1:32 p.m. and it was not accepted. The hospital submitted an IJ Plan of Removal (Version Four) on 8/1/24 at 3:54 p.m. it was reviewed and accepted at 4:57 p.m. with the DQ. On 8/1/24 and 8/2/24 the survey team validated that staff were able to look up AHPs to see what privileges they had and see if concurrent proctoring was still needed, observations done in surgical department to confirm concurrent proctoring was being done, and education as to why this was important was interviewed to. Review concurrent proctoring forms and surgery schedule for 8/1/24 and 8/2/24 there was overlap seen of the same proctor being used and the DQ, CMO and MSD confirmed the proctor was only in the room during the most important times and not the whole surgery. The DQ, CMO, and MSD confirmed this was the process being used and stated the Medical Staff Bylaws and policies were being updated and felt this was safe care their patients. They provided a written statement signed by the CMO and the President of Medical Staff (MSP) indicating above, and MSD stated she would add a statement at the bottom of the proctor forms that the proctor must check attesting that they were present during the most important times of the cases. On 8/2/24 at 3 p.m. while onsite the IJ was removed with CMO, DQ, QIM and MSD. Findings: During a record review on 7/23/24, the roster of the hospital’s Medical Staff members (physicians) and AHP Staff members was reviewed, and a list of staff was selected and provided to the hospital in preparation for credential file review. During an observation on 7/24/24 at 7:11 a.m., certified registered nurse anesthetist (CRNA) 1, assessed Patient (Pt) 17, discussed the anesthesia options with Pt 17 for her scheduled surgical procedure, and obtained Pt 17’s signed consent. During an observation on 7/24/24 from 7:37 a.m. until 8:43 a.m. in the outpatient surgical center operating room (OR) 1, CRNA 1 was the only anesthesia provider for Pt 17’s entire surgery. During a review of the Case Information (CI) record for Pt 17’s surgery dated 7/24/24, the CI indicated that CRNA 1 was the Anesthesia Staff for Pt 17’s surgery. There was no other anesthesia provider’s name on the CI record. During a review of the Anesthesia Record (AR) for Pt 17’s surgery dated 7/24/24, the AR indicated the Responsible (anesthesia) Provider was CRNA 1, and the type of anesthesia was general (when medications are administered to render the patient unconscious). During an interview on 7/24/24 at 10:55 a.m. with the Manager of Surgical Services (MG) 1, MG 1 stated the surgery schedulers have to verify the doctor’s privileges. MG 1 stated the practice coordinators can look up privileges if there is a question about the doctor’s privileges, but the schedulers are the ones that look the privileges up when they schedule the surgeries. During an interview on 7/24/24 at 11:25 a.m. with the Lead Surgery Scheduler (SS), the SS stated the issue of proctoring is between the surgeons and medical staff office (MSO). The SS stated surgery scheduling does not deal with or monitor proctoring, MSO handles it and would let surgery scheduling know. During an observation on 7/25/24 at 9:34 a.m. in OR 4, CRNA 2 (a CRNA) assisted Pt 16 onto the OR table and initiated Pt 16’s anesthesia. CRNA 2 was the only anesthesia provider for Pt 16’s entire surgery. During a review of the Case Information (CI) record for Pt 16’s surgery dated 7/25/24, the CI indicated that CRNA 2 was the Anesthesia Staff for Pt 16’s surgery. There was no other anesthesia provider’s name on the CI record. During a review of the Anesthesia Record (AR) for Pt 16’s surgery dated 7/25/24, the AR indicated the Responsible (anesthesia) Provider was CRNA 2, and the anesthesia type was spinal (a local anesthetic is placed directly in the intrathecal space in the lumbar spine. Used for procedures involving the lower abdomen, pelvis, and lower extremities). During a concurrent interview and record review on 7/25/24 at 1:45 p.m. with the Director of Medical Staff Services (DMSS), CRNA 1’s credential file was reviewed. The DMSS stated the AHPs are not members of the medical staff but the medical staff process for credentialing, privileging, proctoring, appointment, and reappointment is followed for the AHPs as indicated in the medical staff bylaws, policies and procedures, and rules and regulations. Review of CRNA 1’s credential file indicated CRNA 1 was a CRNA who completed his initial AHP staff application on 1/10/23 and was appointed to the Provisional (temporary) AHP staff on 6/1/23. The DMSS stated prior to the appointment date, CRNA 1 was granted temporary clinical privileges from 4/10/23 to 5/31/23 due to the meeting schedule of the Board of Trustees, who have the final approval for appointments of the AHP staff and the Medical Staff. The DMSS stated all initial appointments to the AHP staff are Provisional, and the provisional AHP appointment lasts a minimum of six months, and no longer than two years. A review of CRNA 1’s “CRNA Privilege Form” completed with his initial appointment to the AHP Staff, indicated CRNA 1 requested and was granted CRNA Core Privileges which included Pre-anesthesia Evaluation and Anesthesia Care Plan, Intraoperative Care, and Post-operative Care. The privilege form indicated for the initial appointment there was a requirement for proctoring (the process of observation, by a proctor [an AHP or physician with privileges at least equivalent to the privileges granted to the person to be proctored] in order to evaluate the AHP’s proficiency in the exercise of the clinical privileges initially granted). The privilege form indicated the first four cases performed by CRNA 1 were to be concurrently proctored (proctoring that requires the proctor to be physically present during the care of a patient to observe the performance of the procedure by the AHP being proctored). The privilege form indicated after the four concurrently proctored cases were completed, there was a requirement for retrospective proctoring (review of the medical record following a procedure or period of patient care to assess the quality of performance and documentation). The DMSS stated both concurrent and retrospective proctoring require the proctor to complete a written report evaluating the performance of the person being proctored and to turn that evaluation in to the MSO. The forms completed during the proctoring of CRNA 1 were requested. The DMSS stated no completed proctor forms were submitted to the medical staff office for CRNA 1. The DMSS stated that despite the medical staff office not having evidence that required proctoring was completed, CRNA 1 did not have any privilege restrictions. The DMSS stated she did not know how many cases CRNA 1 had performed independently. The DMSS stated the MSO had not been able to follow up on the proctoring status of the AHPs. The DMSS stated the hospital’s credentialing database (MSOW) has a place to indicate the proctoring requirements for each AHP and their progress towards completion of proctoring, however that information had not been obtained and entered into MSOW yet, so it was not available to anyone wanting to access this information. During a concurrent interview and record review on 7/25/24 at 3:15 p.m. with the DMSS, Physician Assistant (PA) 1’s credential file was reviewed. PA 1 was a Physician Assistant (PA) in the Emergency Department (ED) who was initially appointed to the Provisional AHP Staff on 2/1/22 and was reappointed as regular AHP Staff on 2/1/24. Review of the privilege request form completed for PA 1’s reappointment, indicated PA 1 requested and was granted procedural privileges to perform thoracentesis (a needle or tube is inserted to remove fluid from around the lung; the needle/tube is removed after the procedure), chest tube insertion (a tube is inserted into the area between the chest wall and the lungs to drain air, blood, bile, pus, or other fluids, and left in place), paracentesis (a procedure to remove fluid from the peritoneal cavity [the space within the abdomen that contains the intestines, the stomach, and the liver]), lumbar puncture (a procedure to obtain and sample cerebrospinal fluid from the spinal cord in the lumbar spine), and central line placement (insertion of a catheter into a large [central] vein in the neck, upper chest or groin). The DMSS stated six proctored cases were required for each of these non-core privileges. The record of proctored cases was requested. The DMSS stated she does not have any information about how many cases, if any, had been proctored for each of the privileges. The DMSS stated PA 1 did not have any restrictions on her privileges and the information regarding the proctoring requirements and status of completion had not yet been entered into MSOW. During a concurrent interview and record review on 7/25/24 at 3:25 p.m. with the DMSS, NP 1’s credential file was reviewed. The file indicated NP 1 was a Nurse Practitioner in Cardiovascular Surgery who was initially appointed to the provisional AHP staff in 2021 and was reappointed to the regular AHP Staff on 6/1/23. Review of NP 1’s privileges indicated NP 1 had RN First Assistant (RNFA) privileges for surgery, NP core privileges and procedural privileges, and also cardiology/vascular surgery non-core privileges. NP 1 had no restrictions on her privileges. Review of the privilege information in MSOW confirmed NP 1 had the same privileges as what was reflected on the paper privilege form in the credential file. MSOW did not have any proctoring information. The DMSS provided evidence that the proctoring requirements for the RNFA privileges had been completed. The proctoring requirements for the core privilege “Discharge Patients” required review of the first three cases discharged, with completion of a written evaluation. The DMSS stated she did not have any proctor forms, evaluations, or other evidence to indicate this requirement had been completed. For the NP procedural privileges which included paracentesis, thoracentesis, central line placement, chest tube insertion, lumbar puncture, and removal of a tunneled catheter (a central venous catheter that is tunneled through a space under the skin and has both and entry and an exit site which provide stability to allow long term use), the proctoring requirements were six cases for each procedure, except for lumbar puncture which required five proctored cases. The DMSS stated she did not have any proctor forms for any of these procedures. The non-core NP privileges for cardiology and vascular surgery included chest tube removal, removal of temporary pacing wires (inserted during cardiac surgery and left in place for the post operative period in case the patient develops an abnormal heart rhythm), endoscopic vein harvest (EVH-a procedure to remove a vein in the leg for use in coronary artery bypass graft [CABG] surgery), radial artery (RA) harvest (a procedure to remove a blood vessel [RA] in the arm for use in CABG surgery) and percutaneous removal of an intra-aortic balloon pump (IABP- a device placed in the aorta [large artery that carries blood away from the heart to the rest of the body] in order to help the heart pump blood). The DMSS provided NP 1’s proctor forms for removal of chest tubes and removal of temporary pacing wires. The DMSS stated did not have any evidence of proctored cases for percutaneous removal of an IABP which required two proctored cases, the EVH procedure which required three proctored cases, or the RA harvesting procedure which required three proctored cases. The DMSS stated she does not have any information regarding the status of NP 1’s proctoring for these procedures, and does not know how many of these procedures NP 1 had performed. During a concurrent interview and record review on 7/29/24 at 10:40 a.m. with the DMSS, CRNA 2’s credential file was reviewed. The credential file indicated CRNA 2 was a CRNA who was given temporary privileges on 6/10/24 and was appointed to the Provisional AHP staff on 7/1/24. A review of CRNA 2’s “CRNA Privilege Form” completed with his appointment to the AHP Staff, indicated CRNA 2 requested and was granted CRNA Core Privileges which included Pre-anesthesia Evaluation and Anesthesia Care Plan, Intraoperative Care, and Post-operative Care. There were no restrictions on CRNA 2’s privileges. The privilege form indicated for the initial appointment there was a requirement for concurrent proctoring of the first four cases performed by CRNA 2, followed by retrospective proctoring of four additional cases. The DMSS provided evidence of one concurrently proctored case which was completed on 7/11/24. The DMSS stated CRNA 2 was being proctored on the other three required cases on 7/29/24. The DMSS stated she does not know how many cases CRNA 2 had performed without a proctor. During a review of the Surgery Log (A list of all surgeries and procedures done in the hospital and outpatient center, along with the names of the surgeons and anesthesia providers responsible for each case) for 6/1/24 through 7/31/24, the log indicated CRNA 2 was the anesthesia provider for eighteen cases from 7/10/24-7/28/24 (does not include the proctored case on 7/11/24), prior to completing all of the required concurrent proctored cases. During a concurrent interview and record review on 7/29/24 at 11:25 a.m., with the DMSS, the DMSS provided an update on the proctoring status of CRNA 1. The DMSS stated she had contacted the anesthesia medical director (AMD) on 7/25/24, and on 7/26/24 the AMD provided four completed concurrent proctor forms dated 1/3/24, 1/15/24, and two dated 1/26/24 and four retrospective proctor forms. The DMSS stated the forms were not provided in a timely manner to the MSO, and the MSO did not have a system in place to follow up on the AHP staff’s outstanding proctoring requirements. During a concurrent interview and record review on 7/29/24 at 11:50 a.m., with the DMSS, the DMSS stated the AMD had been following up on the proctoring status of all of the provisional CRNAs and had submitted some completed proctor forms to the MSO. The status of CRNA 3 and CRNA 4 proctoring was reviewed. The DMSS stated CRNA 3 was granted temporary privileges on 4/10/23 and was appointed to the provisional AHP staff on 6/1/23, and CRNA 4 was granted temporary privileges on 4/8/24 and was appointed to the provisional AHP staff on 5/1/24. The DMSS stated the AMD had provided the proctor forms for CRNA 3 and CRNA 4 the morning of 7/29/24. A review of the proctor forms indicated the forms were not completed properly and were missing the AHP’s full name, the date of the procedure and the type of proctoring (retrospective or concurrent). The DMSS confirmed these forms would not be accepted and they would be sent back to the AMD. There was no record of other proctored cases for CRNA 3 or CRNA 4. During an interview on 7/29/24 at 1:40 p.m. with the DMSS, the DMSS provided an update on the proctoring status of PA 1 and NP 1. The DMSS stated the medical director of the ED (EDMD) was contacted about PA 1 and the need for documentation of the cases that were proctored for PA 1. The DMSS stated that a new proctoring plan for PA 1 was put in place for each of the five procedures until there is validation that proctoring requirements have been completed. The DMSS stated after the review of NP 1’s file on 7/25/24, the DMSS contacted NP 1 by email about her privileges and required proctoring. The DMSS stated NP 1 indicated she does not perform thoracentesis, paracentesis, central line placement, removal of a tunneled catheter, or radial artery harvesting and withdrew her request for those privileges. The DMSS stated NP 1 was put back on proctoring for review of three discharges, and for concurrent proctoring of three cases of endoscopic vein harvest, and two cases of IABP removal. The DMSS stated at the time of appointment, all members of the AHP staff and the medical staff are made aware of the requirements for proctoring. The DMSS stated the proctoring policies had not been followed. During an interview on 7/30/24 at 4:55 p.m. with the Director of Quality (DQ), an updated list of all of the AHPs and the status of their proctoring was requested. The DQ stated this would take time because it is a manual process to get this information. During an interview on 7/30/24 at 5 p.m. with the DMSS, the DMSS stated it would not be possible at this time to assess and report the proctoring status of all of the provisional AHPs because that information has not been entered into MSOW so each AHPs file would have to be reviewed for the proctor forms. The DMSS stated the MSO staff is focusing on updating MSOW with the current proctoring status of the provisional CRNAs first, and then will work on the NPs and PAs. The DMSS stated that currently there were approximately forty provisional members of the AHP staff require follow up to determine what proctoring has been done, what forms have been turned in, and what still needed to be completed. The proctoring requirements for each AHP and their progress towards completion had to be updated in MSOW so the information could be available to the staff in the hospital. During a record review on 7/30/24, the “Anesthesia Daily Schedule-Next Day” was reviewed. The schedule indicated CRNA 5 was scheduled to be proctored for four cases on 7/31/24. Review of the CRNA roster indicated CRNA 5 was granted temporary privileges on 7/8/24 and had not completed any concurrently proctored cases. During a review of the Surgery Log for 7/2024, the log indicated CRNA 5 was the anesthesia provider for twenty cases prior to being scheduled for the four required concurrently proctored cases on 7/31/24. During a record review on 7/30/24, the “Anesthesia Daily Schedule-Next Day” was reviewed. The schedule indicated CRNA 6 was scheduled to be proctored for three cases on 7/31/24. Review of the CRNA roster indicated CRNA 6 was granted temporary privileges on 4/10/23, was appointed to the provisional AHP staff on 6/1/23, and had not completed any concurrently proctored cases. During a review of the Surgery Log for 6/1/24-7/30/24, the log indicated CRNA 6 was the anesthesia provider for thirty cases prior to being scheduled for any concurrently proctored cases. During a record review on 7/31/24, the CRNA roster was reviewed. The roster indicated CRNA 7 was granted temporary privileges on 4/8/24, was appointed to the provisional AHP staff on 5/1/24, and had not completed any proctored cases. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 7 was the anesthesia provider for sixteen cases. During a record review on 7/31/24, the CRNA roster was reviewed. The roster indicated CRNA 8 was appointed to the provisional AHP staff on 10/1/23, and had completed two of the four required concurrently proctored cases, no date of completion recorded on the roster. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 8 was the anesthesia provider for forty-four cases in those two months without having first completed the required concurrently proctored cases. During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 9 was granted temporary privileges on 3/4/24, was appointed to the provisional AHP staff on 4/1/24, completed the required concurrently proctored cases on 7/30/24 and the proctor forms were turned into the MSO on 7/30/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 9 was the anesthesia provider for ninety-six cases in those two months without having first completed the required concurrently proctored cases. During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 10 was granted temporary privileges on 6/10/24, completed the required concurrently proctored cases on 7/31/24, and the proctor forms were turned into the MSO on 7/31/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 10 was the anesthesia provider for seventeen cases without having first completed the required concurrently proctored cases. During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 11 was granted temporary privileges on 6/10/24, completed the required concurrently proctored cases on 7/29/24 and the proctor forms were turned into the MSO on 7/30/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 11 was the anesthesia provider for forty-five cases without having first completed the required concurrently proctored cases. During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 12 was appointed to the provisional AHP staff on 6/1/23, completed the required concurrently proctored cases on 7/30/24 and the proctor forms were turned into the MSO on 7/30/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 12 was the anesthesia provider for twenty-eight cases in those two months without having first completed the required concurrently proctored cases. During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 13 was granted temporary privileges on 3/4/24, was appointed to the provisional AHP staff on 4/1/24, and completed three of the four required concurrently proctored cases, no date of completion recorded on roster or date the proctor forms were turned into the MSO. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 13 was the anesthesia provider for fifty-four cases in those two months without having first completed the required concurrently proctored cases. During a record review on 8/1/24, the CRNA roster was reviewed. The roster indicated CRNA 14 was granted temporary privileges on 6/3/24, was appointed to the provisional AHP staff on 7/1/24, completed the required concurrently proctored cases on 7/29/24, and the proctor forms were turned into the MSO on 7/30/24. During a review of the Surgery Log for 6/1/24-7/31/24, the log indicated CRNA 14 was the anesthesia provider for one hundred five cases without having first completed the required concurrently proctored cases. During a concurrent interview and record review on 8/2/24 at 12:30 p.m. with the DMSS, an updated provisional AHP roster was reviewed. The AHP roster was divided into CRNAs, PAs and NPs. The CRNA roster indicated there were twenty-four provisional CRNAs. The DMSS stated four of the CRNAs were placed on a leave of absence on 7/25/24 because they had not worked since being appointed to the provisional AHP staff. The roster indicated there were fourteen CRNAs who had completed the required proctored cases and six others who were in the process of completing proctoring. The DMSS stated over the previous couple of days the MSO staff had inputted the proctoring requirements for each AHP with provisional privileges into MSOW so staff will now be able to look up the AHPs to verify privileges and whether proctoring has been completed. Review of the PA and NP rosters indicated there were twelve provisional PAs and thirty-two provisional NPs. The PAs and NP roster spreadsheets did not contain the information regarding how many concurrent or retrospective proctored cases were completed, or when they were completed, or how many were still needed like the CRNA roster did. The DMSS stated the roster spreadsheet was created manually and the details were populated for the CRNAs by the MSO staff. The DMSS stated although the information regarding the proctoring is not on the spreadsheet for the PAs and NPs, the information about whether or not a PA or NP required concurrent proctoring has been entered into the MSOW database for staff to look up. MSOW was accessed to look up three PAs and three NPs off of the roster to validate the information regarding concurrent proctoring status was there. During a review of the policy and procedure (P&P) titled, “Proctoring/Observation Requirements for Medical Staff Members,” dated 7/28/17, the P&P stated, “ ...each Provisional Staff member shall undergo a period of observation by designated monitors ...The observation shall be to evaluate the Member’s proficiency in the exercise of clinical privileges initially granted and over-all eligibility to continued Staff membership and advancement within staff categories ...Definitions: Proctoring- The process of observation by a monitor/proctor, for the purpose of evaluation and appraisal of skills, performance, judgment and behavior of a practitioner ...Concurrent Proctoring- proctoring which requires the monitor to be physically present during the care of a patient undergoing a procedure for observation of performance [Same as direct observation and supervised privileges] ...Proctoring should include the complete management of the patient ...A written proctoring form will be completed by the proctor and returned to the Medical Staff Office no later than one week of direct observation of the procedure ...A report of proctoring progress shall be reported to the Medical Executive Committee and the Board of Trustees on a monthly basis ...” During a review of the P&P titled, “Surgery Proctoring,” dated 4/9/19, the P&P indicated, “ ...All members, either provisional or active, who need to be proctored will assure that a proctor is aware of cases to be proctored. To facilitate the process, the medical staff office will notify the surgery scheduling staff of the need for that member to be proctored and who the assigned proctor will be. If and when the member falls below the threshold to fulfill the required number of minimum cases to be proctored, the department chairman will be notified who in turn, will contact the member. The member will not be allowed to continue to perform these procedures until the proctoring requirement is fulfilled. Proctoring will include evaluation of the preop, intraop, and postop management ...” During a review of the hospital document titled, “Bylaws of the Medical Staff,” dated 7/27/18, the document indicated, “ ...General Policies applicable to Allied Health Professionals- No person shall be entitled to perform services solely because he or she holds a certain degree, is licensed to practice in this or any other state, is a member of any professional organization, is certified by any clinical board, or because such person had, or presently has, been able to perform services at another health care facility ...The AHP shall sign an agreement to abide by the Hospital and Medical Staff Policies/Procedures and the Bylaws of the Medical Staff ...” During a review of the hospital’s “Allied Health Professional Policy/Procedure Manual,” dated 5/23, the manual indicated, “ ...Requirements for Service Authorization and Criteria For Approval of Certified Registered Nurse Anesthetist [CRNA]-Proctoring of CRNAs: The applicant will be monitored for a minimum of four concurrent and four retrospective cases. The applicant will be given six months of provisional privileges to complete the monitoring process, following which a recommendation will be made to the appropriate committee to continue or discontinue monitoring ...” During a review of the hospital’s “Allied Health Professional Policy/Procedure Manual,” dated 5/23, the manual indicated, “ ...Duties of the Allied Health Professional- Upon appointment, each AHP shall be expected to: ...Comply with all Medical Staff and Hospital Bylaws, Rules and Regulations, and the Allied Health Professional Policies and Procedures ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 37529 Based on observation, interview, and record review, the hospital failed to ensure nursing staff followed hospital policies and procedures (P&P) when: 1.The “Medication Reconciliation”, “Documentation”, and “Emergency Department Arrival (Triage), Documentation, and Discharge,” was not followed for Pt 1. These failures resulted in medication reconciliation (The process of identifying the most accurate list of all medications that a patient is taking and comparing that list against a physician’s admission, transfer, and/or discharge orders to avoid medication errors) not being performed properly and had the potential to cause harm to all patients. The failure to perform medication reconciliation for Pt 1 resulted in Pt 1 not receiving medication needed to control atrial fibrillation (AFib- an arrhythmia that occurs when the upper chambers of the heart [atria] beat irregularly and fast), which led to Pt 1 having AFib with rapid ventricular response (RVR- occurs when the rapid contractions of the atria cause the ventricles [the lower chambers of the heart] beat too fast) which led to Pt 1’s transfer to a higher level of care, prolonged her hospital stay and placed her at increased risk for stroke. 2.Hospital nursing staff failed to follow their policies and procedures to reduce the risk of skin breakdown when Patient (Pt) 18 did not have a documented pressure relieving interventions every two hours on multiple shifts between 5/30/24 to 6/10/24 for the left heel in accordance with the facility policy. These failures resulted in the worsening of left heel discoloration to unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough [yellow, tan, gray, green, or brown]) pressure injury on the left heal and the potential delayed nursing care for the pressure injury. 3. One of one patient (Pt 22) did not have blood glucose (sugar in the blood) monitoring completed according to the hospital’s P&P titled, “Hyperglycemia/Hypoglycemia Treatment.” This failure had the potential for Pt 22 to have continued low blood glucose levels and a decline in health status. 4. One of four patient (Pt 23) did not have baseline vital signs (blood pressure, heart rate/rhythm, respiratory rate, oxygen saturation) and pain assessment completed prior to a procedure according to the hospital’s P&P titled, “Sedation/Analgesia, Moderate.” This failure had the potential to miss a change of condition for Pt 23. 5. One of two patient (Pt 23) did not receive discharge instructions in Spanish according to the hospital’s P&P titled, “Discharge Planning.” This failure had the potential for Pt 23 to not understand how to care for herself after her procedure. 6. Two of four patients (Pt 24 and Pt 25) did not have an assessment completed in the initial recovery period after their procedures were completed according to the hospital’s P&P titled, “Documentation, Endoscopy.” This failure had the potential to miss a change of condition for Pt 24 and Pt 25. 7. Two of two patients (Pt 27 and Pt 28) did not have their wound incision assessed and documented when transferred to postpartum (mother-baby unit) per the hospital’s P&P titled, “Postpartum Care.” This failure placed Pt 27 and Pt 28’s wound incision at risk for infection, deterioration, and/or wound separation. 8. One of one patient (Pt 27) did not have an interpreter used when signing a consent form for a cesarean section according to the hospital’s P&P titled, “Informed Consent/Consent Forms.” This failure had the potential for Pt 27 to not understand the procedure she was having. Findings: 1. During a concurrent observation and interview on 7/22/24 at 11:10 a.m. in the Emergency Department (ED) with the Director of the ED (DED), the DED stated the ED has a pharmacy that is open daily for day shift and pm shift from 7 a.m. until 11 p.m. The DED stated there is a Medication Reconciliation Tech (MRT- a pharmacy employee) scheduled on the day shift and on the pm shift and they start the medication reconciliation (med rec) process for the admitted and observation patients in the ED who are waiting to be moved to a hospital room. The DED stated on night shift when there is not a MRT scheduled, the day shift MRT should follow up in the morning if the patient is still in the ED, if not the med rec process is started by the nursing staff on the unit where the patient was admitted. The DED stated the nursing staff in the ED can start the process by asking the patient or family about medications taken at home. The DED stated if a patient or family member brought in a list of the home medications the nursing staff should make a copy of it and put it in the patient’s chart. The DED stated the process of the MRT completing the home medication (Prior to Admission [PTA]) list is for patients that have been admitted to the hospital but are in the ED. During an interview on 7/23/24 at 9:38 a.m. with Pt 1’s family member (FM)1, FM 1 stated Pt 1 was 90 years old and lived at home with her husband. FM 1 stated Pt 1 had a history of back pain, Pt 1 was taken to the ED by ambulance on 7/1/24. FM 1 stated Pt 1’s medical history included hypertension, atrial fibrillation, and Pt 1 had a pacemaker (an implanted medical device used to control an irregular heart rhythm). FM 1 stated Pt 1 had to wait in a bed in the hallway until a pacemaker representative come to the hospital the morning of 7/2/24. FM 1 stated while Pt 1 was in the ED, she brought in a list of Pt 1’s medications and attempted to give the list to the nurse so the medications could be reviewed and ordered. FM 1 stated she was told by the nurse that they (the ED nurses) “don’t do that [medication reconciliation]” and that “it will be done on the unit [inpatient floor in hospital], or pharmacy does it.” FM 1 stated the nurses would not take the list of medications from her to put in Pt 1’s chart. FM 1 stated after Pt 1 was moved to the inpatient bed on the third floor, FM 1 brought Pt 1’s medication list, reviewed it and gave a copy of the list to Pt 1’s nurse. FM 1 stated she did not find out until the late afternoon on 7/5/24 that the list of medications were never entered into Pt 1’s record. FM1 stated Pt 1 did not receive her twice daily medication dronedarone(an antiarrhythmic medication used to treat atrial fibrillation and atrial flutter) for four days. FM 1 stated by that time Pt 1 was in A-fib with rapid ventricular response (RVR- occurs when the rapid contractions of the atria cause the ventricles [the lower chambers of the heart] beat too fast) a rapid response team (RRT- a group of healthcare professionals who are called upon to quickly respond to a patient’s sudden decline in health or emergency situation) was called, and Pt 1 was transferred to the telemetry unit (unit in the hospital where patients undergo continuous cardiac monitoring). FM 1 stated no one gave her an explanation as to why the medications were not reconciled after she had provided a list of the medications to the nurse. FM 1 stated Pt 1 had to stay for several more days in the hospital.FM 1 stated she had serious concerns about the safety of patients at the hospital, and was surprised no one from the hospital ever contacted her after Pt 1’s discharge to discuss what happened or to check on Pt 1’s condition. During a review of Pt 1’s medical record, the ED Provider Note dated 7/1/24 at 8:40 p.m., indicated Pt 1 was a 90 year old woman with a history of chronic back pain, hypertension, cardiac surgery, and permanent pacemaker placement, who came to the ED by ambulance on 7/1/24 at 8:40 p.m. with complaints of lower back pain for the past three days. A review of the ED Patient Care Timeline dated 7/1/24 at 8:40 p.m. to 7/2/24 at 5:39 p.m., indicated Pt 1 was alert and oriented with a Glasgow Coma Scale (GCS- a system to assess a person’s level of consciousness; scored from 3-15 with 15 being fully awake, responsive, and having no problems with thinking ability or memory) score of 15. The Timeline indicated Pt 1 had been scheduled for an outpatient Magnetic Resonance Imaging scan (MRI- uses a magnetic field and radio waves to create detailed images of organs and tissues in the body) but the MRI had not been done yet because Pt 1 has a pacemaker (an implanted medical device used to control an irregular heart rhythm. The pacemaker needs to be checked before an MRI to verify it is MRI compatible). The Timeline indicated the representative from the pacemaker supplier would evaluate Pt 1’s pacemaker on 7/2/24 at 8 a.m. The Timeline indicated Pt 1’s pacemaker was determined to be compatible with the MRI, the scan was completed at 11:34 a.m. on 7/2/24 and the results indicated Pt 1 had a L3 compression fracture (a break or crack in a vertebra [the bones that make up the spine]; L 3 refers to the one of the five vertebra that make up the lumbar spine [lower back]). The ED Provider note indicated Pt 1 required hospital admission and would have a kyphoplasty (minimally invasive procedure to treat vertebral compression fractures; a balloon is first inserted into the fractured bone to create a cavity or space, then cement is injected into the cavity) on 7/3/24. The ED Provider note for Pt 1 indicated, “Home Medications: Reviewed, Per Nurses Notes,” there were no ED nurses notes addressing home medications. Admission orders for Pt 1 were placed on 7/2/24 at 3:16 p.m. by MD 8 which included an order for “Pharmacy General Consult.” Review of Pt 1’s history and physical (H&P) note by MD 8 dated 7/2/24 at 3:10 p.m., the H&P indicated, “ ...Past medical history [PMH] of A-fib on [brand name medication used to reduce the risk of stroke and blood clots in people who have atrial fibrillation], Sick Sinus Syndrome [SSS- a type of heart rhythm disorder which affects the heart’s natural pacemaker] status post pacemaker, L 2 compression fracture status post kyphoplasty in 2017 ...” Pt 1 was transferred to the third floor (3 West) on 7/2/24 at 5:39 p.m. On 7/2/24 at 6:45 p.m. FM 1 brought Pt 1’s home medication list in to the hospital and gave it to RN 5. RN 5 passed the list on to RN 6 to enter into the EHR. On 7/3/24 Pt 1 had a kyphoplasty for a spinal compression fracture. On 7/5/24 Pt 1 had an epidural injection for pain management and during the procedure she developed A-fib with RVR, a rapid response team was called, Pt 1 was given intravenous metropolol (medication used to treat high blood pressure) and was transferred to the telemetry unit. During an interview on 7/23/24 at 12 p.m. with ED Registered Nurse (RN) 8, RN 8 stated she prioritizes obtaining a home medication history for patients who are in the ED with mental health (MH) conditions. RN 8 stated while other patients who have admission orders will have med rec completed once they get to their hospital room, patients with MH conditions requiring admission may need to stay in the ED for days. RN 8 stated if a patient or family brings in a list of home medications she would take a copy and put it in the patients chart. During an interview on 7/23/24 at 12:20 p.m. with the MRT, the MRT described her role in the med rec process for ED patients with inpatient admission or observation orders. The MRT stated she reviews the physician’s progress notes and the Medication Dispense History (a report in the patient’s electronic health record [EHR] that shows a record of what medications were prescribed and filled at outside pharmacies) and speaks with the patient. The MRT stated she asks the patient to name as many of their home medications as possible and then she reviews the printout of all of the medications and asks when the patient last took each medication. The MRT stated this information is entered into the “prior to admission [PTA] medication” section of the admission tab in the EHR. The MRT stated if the patient is unable to provide information regarding their home medications, she calls the family and/or the outside pharmacy listed on the report in order to obtain information about the patient’s home medications. The MRT stated it is very helpful when the patient or family member brings in a list of the medications the patient is taking. The MRT stated the RN admitting the patient on the admitted unit will still need to review the medication list within the PTA medication section. The MRT stated the most difficult part of her job is there is only one MRT on during the day and one on the pm shift, and there is no one on at night. The MRT stated when she starts her shift in the morning she has the patients in the ED with admit or observation orders from the previous night in addition to the new patients that come in during the day. The MRT stated she organizes her work to do the patients in the order of how long they have been in the ED, however she frequently gets requests to prioritize a patient, and is not always able to get to every patient because of the number of patients. During a concurrent interview and record review on 7/23/24 at 2:30 p.m. with RN 5, Licensed Vocational Nurse (LVN) 1, and the nursing director for the medical floor (DON) 2, Pt 1’s medical record for 7/2/24 was reviewed. RN 5 and LVN 1 were assigned to care for Pt 1 when she was admitted from the ED to the third floor on 7/2/24. RN 5 and LVN 1 both stated they did not remember any specific details about Pt 1 since it had been three weeks since she was admitted, but they had reviewed the record. RN 5 stated Pt 1 arrived to her room on the third floor around 5:45 p.m. and Pt 1’s daughter came in after 6 p.m. with a list of all of Pt 1’s home medications. RN 5 stated she took the list of medications but did not start the medication reconciliation process at that time because it was almost shift change and she was preparing for report to the oncoming shift. RN 5 stated during report she handed off the med list to the oncoming RN and let him know the med rec still needed to be done. RN 5 stated she did not know what happened to Pt 1’s med list after that. RN 5 stated the admitting nurse’s role in med rec is to obtain the information about the patient’s home medications, the dose and when they were last taken and input the information into the PTA med list in the EHR. RN 5 stated if a patient does not know their medications, she could call the family. RN 5 stated after the PTA med list is completed there is a place to check that they are reviewed. RN 5 stated she thinks the med list then goes to pharmacy and then the physician to order. RN 5 stated she was not sure of the process to follow if there is another PTA med to add after the meds are reviewed. RN 5 stated if the admitting nurse does not get the med rec started they would pass that information on during report so the oncoming RN would know it still needs to be completed. RN 5 stated she is not aware of a way a nurse would be alerted that med rec had not been done. RN 5 stated she would have to “use her judgment” if patient with a long medical history did not have any home medications noted in the medical record. RN 5 stated she took care of Pt 1 on another day but does not recall an issue with med rec. Review of the EHR “secure chat” messages for 7/2/24 on admission indicated at 6:42 p.m. the admitting physician (MD 8) sent a chat message, “[Please] reconcile her home meds so that I can resume them.” RN 5 sent a reply at 6:49 p.m., “Yes, patient’s daughter just brought the med list, oncoming nurse will put the meds in.” At 7 p.m., MD 8 sent a chat message, “Please reconcile the meds so I can start them.” The message was read at 7:04 p.m.by RN 5 and LVN 1. At 7:53 p.m. MD 8 sent a chat message, “Hi I requested the home meds to be reconciled here to resume them since the morning, can you do it [please]?” The oncoming RN (RN 6) responded at 7:54 p.m., “The a.m. nurse notified me about it. I put the meds already.” At 7:55 p.m. MD 8 sent a chat message, “I still don’t see them from my end.” RN 6 responded at 7:56 p.m., “Let me verify.” There was no further documentation in the chat or the nurses notes by RN 6 regarding Pt 1’s medication list. The DON 2 stated RN 6 is a traveler nurse. DON 2 stated she does not have any information about what happened to the medication list or why RN 6 did not enter the medications because his communication in secure chat with MD 8 ended. DON 2 stated she would follow up with RN 6 to find out what happened. The DON 2 stated she did not know why Pt 1’s nurses on 7/2, 7/3, 7/4 or 7/5 did not follow up on Pt 1’s home medications. During a review of Pt 1’s medical record, the physician progress notes completed by MD 7 on 7/3/24, 7/4/24, 7/5/24, and 7/6/24 were reviewed. The progress notes indicated under the “Plan section” of the progress notes for 7/3/24 and 7/4/24, “ ...[History] of Afib- No med rec available unfortunately; unclear why it has not yet been done ...” Review of MD 7’s progress note for 7/5/24, indicated, “ ...A fib RVR-unfortunately med rec not done despite family providing home med list ...” During an interview on 7/24/24 at 10:20 a.m. with DON 2, DON 2 stated she had spoken with RN 6 about Pt 1’s medication list, and RN 6’s secure chat messages with MD 8. DON 2 stated RN 6 indicated on the night of 7/2/24, RN 6 was distracted and forgot to follow up on MD 8’s question about Pt 1’s home medications. During an interview on 7/24/24 at 12:45 p.m. with RN 7, RN 7 stated she was the RN assigned to Pt 2 on 7/8/24. RN 7 stated Pt 2 was being discharged and part of the discharge process involved printing the after visit summary (AVS- a document which summarizes the patient’s hospital stay, includes a list of the patient’s medications, and identifies any medication changes, diet and activity instructions, follow up appointments, and information about the patient’s medical conditions and discharge diagnosis). RN 7 stated the AVS cannot be printed unless the discharge medication reconciliation process has been completed. The AVS includes a list of all medications with the direction to start, continue, or stop and what time each of them should be taken next. RN 7 stated she did not notice a discrepancy between the indication for each medication and Pt 2’s diagnoses or medical conditions. RN 7 stated she printed the AVS and reviewed it with Pt 2’s daughter who was Pt 2’s caregiver. RN 7 stated Pt 2’s daughter told her that many of the medications on the AVS were not medications prescribed for Pt 2 before. RN 7 stated she reviewed each medication with Pt 2’s daughter who indicated which meds Pt 2 was taking and which ones Pt 2 had not been taking. RN 7 stated on the printed AVS document she wrote an “X” next to each of the medications Pt 2 was not taking before giving the AVS document to Pt 2’s daughter. RN 7 stated she sent a message through secure chat to the discharging physician (MD 6) informing him that there were medications on Pt 2’s discharge medication list that Pt 2 does not take. During a review of the secure chat messages in Pt 2’s EHR dated 7/8/24, the EHR indicated a chat message was sent to MD 6 by RN 7 at 4:32 p.m. The message indicated, “Hi doctor I was going over the AVS with daughter, she said her mom (Pt 2) is not on any heart medications. She is saying she has never given her [apixaban], [atorvastatin], [dronedarone], Benazepril, Metoprolol. Would you happen to know if she should start taking these or should family follow up with PCP [primary care provider- patient’s doctor]?” MD 6 responded in the chat at 4:36 p.m., “Follow with PCP. Those are her PCP meds on file.” During a review of Pt 2’s “Reconciliation Audit” ( a report listing the med rec activity for each medication at admission and discharge) for 7/1/24-7/8/24, the audit indicated on 7/2/24 at 7:42 p.m., RN 6 entered five medications in the prior to admission (PTA) meds list (home medications) for Pt 2, and indicated the last dose taken had been on 7/1/24. The audit indicated MD 6 had completed the discharge reconciliation which included five of the medications to “Resume at Discharge.” The medications were [apixaban (to reduce the risk of stroke and blood clots in people who have atrial fibrillation)], [atorvastatin (a medication used to treat high cholesterol)], metoprolol ( a medication designed to slow down the heart rate in individuals with A-fib), [dronedarone (a medication to help control irregular heart rhythm in patients with AFib] , and [Benazepril (treats high blood pressure]. A review of Pt 2’s record indicated Pt 2 did not have A-fib, or hypertension and had not been prescribed these medications before. During a review of the printed AVS with the discharge medication list, provided by RN 7 to Pt 2’s daughter on 7/8/24, the discharge medication list had an “X” written (by RN 7) next to five of the eight medications ordered at discharge to indicate that Pt 2 does not take these medications. A review of Pt 2’s home medication list entered into the EHR on 7/2/24, the home medication list included the same five medications Pt 2’s daughter indicated Pt 2 did not take. The two lists were contradictory and indicated the medication were not reconciled correctly. During a record review on 7/24/24 at 4 p.m., the hospital’s EHR report of compliance with Admission Medication Reconciliation for 1/1/24 through 7/24/24 was reviewed. The report contained a list of twenty-six patient care areas in the hospital with a month by month percentage of compliance for each area. The report did not give an overall combined compliance rate each month for all areas, but listed the individual months for each area separately. The report indicated for nearly all of the areas, the monthly compliance rate for completion of the admission medication reconciliation (within 24 hours after admission) was between 0% and 50%. The report indicated for 3W (where Pt 1 and Pt 2 were admitted) Station 1, the percentage compliance with admission med rec for January and February 2024 was 0%, March 40%, April 33.3%, May 33.3%, June 33.3%, and for the 3W Station 2, the report indicated January 2024 100%, February 2024 50%, March 40%, April 50%, May 25%, and June 50%. During a record review on 7/25/24 at 11:08 a.m. with the Medication Safety Coordinator (MSP), the MSP stated he was made aware about the report of the compliance rate for admission med rec completion for each area. The MSP stated he did not monitor or review the medication reconciliation compliance in any area of the hospital and did not have reports generated with this information. The MSP stated med rec was not part of the hospital’s Medication Error Reduction Plan (MERP). The MSP stated he wrongly assumed the quality department was monitoring med rec data. During a review of the hospital’s Policy and Procedure (P&P) “Medication Reconciliation,” dated 9/23, the P&P indicated, “ ...The patient’s medication record is assessed at all transition points including admission, transfer, and discharge. The patient’s current home medications are accurately documented and reconciled to ensure continuity of care. Medication Reconciliation: The process of comparing the medication information the patient brought to the hospital with the medications ordered for the patient while in the hospital in order to identify discrepancies including but not limited to omissions, duplications, contraindications, unclear information and changes ...all patients with medication orders will have home medication history collected, documented, and reconciled ...The licensed nurse will be responsible for collecting the medications history. The pharmacist or Medication Reconciliation Pharmacy Technician stationed in the Emergency Department may assist in this process ...Medication history collection, documentation, and reconciliation will occur within 24 hours of admission ...The attending Licensed Independent Practitioner (LIP) will be responsible for performing admission medication reconciliation within twenty-four hours of admission and when a change in level of care occurs ...The discharging LIP will be responsible for performing discharge medication reconciliation ...” During a review of the hospital’s Policy and Procedure (P&P) “Documentation,” dated 10/22, the P&P indicated, “ ...The medical record is a complete and accurate record of each episode of care ...Admission: Medication history is completed within 24 hours of admission ...” During a review of the hospital’s P&P “Emergency Department Arrival (Triage), Documentation, and Discharge,” dated 10/22, the P&P indicated, “ ...Elements obtained during Secondary Assessment by RN/LVN to include patient screenings to be completed at bedside: A. Home Medications B. History ...Items that are part of the patient’s medical record must be scanned into the computer, including but not limited to: Home Medication List ...” 49230 2. During a review of Patient (Pt )18’s “History and Physical (H&P), dated 5/19/24, the H&P indicated, Pt 18 was a 59 year old female with history of Parkinson’s (a progressive disorder that affects the nervous system - brain and spinal cord and the parts of the body controlled by the nerves, affects movement, often including tremors) not on medications, hypertension (high blood pressure), suicide attempt, insulin-dependent diabetes mellitus type2 (is a condition that happens because of a problem in the way the body regulates and uses sugar and requiring insulin), peripheral neuropathy (Weakness, numbness, and pain from nerve damage, usually in the hands and feet) and schizophrenia (is a serious mental health condition that affects how people think, feel and behave) who was brought into the ED by ambulance after ground-level fall. Pt 18 denied having loss of consciousness or having significant head trauma. Pt stated history of multiple ground level falls. H&P indicated in ED pt was noted to have right heel decubitus ulcer containing maggots. During a review of Pt 18’s “nurses note” dated 5/30/24 at 11:00 a.m., the “nurses note” indicated, “During the patient assessment I found patient’s left heel to be purplish in color. I readjusted immobilizer (immobilize a body part using a splint, straps or cast to eliminate motion) on patients’ leg, to prevent friction to heel, added abd [a sterile, all-purpose bandage and wound cleaning pad] cushion between skin and immobilizer and floated the patient’s heel. At [5:00 p.m.] I reassessed patients’ left heel and found no improvement. I ordered a wound consult and replaced the immobilizer with a smaller immobilizer to prevent further skin breakdown.” During a review of Pt 18’s “Wound Care Subsequent Consult” dated 5/31/24, the “Wound Care Subsequent Consult” indicated “ ...Asked to see pt for left heel discoloration. I saw the pt a few days and she had deep purple trauma to the ankle from rubbing against knee immobilizer. She now has a 5x5 area of deep purple discoloration the heel along with scattered transversely liner purple streaks. The main area is over the heel and appears as pressure, however the brace may have precipitated the issue or exacerbated it. Skin intact, small brace in use, and offloading in place. Discussed with pt and [physician name] ...” During a review of Pt 18’s “Wound Care Subsequent Consult” dated 6/10/24, the “Wound Care Subsequent Consult” indicated, “ ...In to re-assess left heel and anterior foot wounds ...The left heel has progressed as expected to an unstageable ulcer (Full thickness tissue loss in which actual. depth of the ulcer is completely obscured by slough (yellow, tan, gray, green, or brown) and/or eschar (tan, brown, or black) in the wound bed) as evidenced by slough at wound base. Site cleaned with [normal saline] and [brand name] gel to wound bed followed by bordered foam to help with debridement as well as moist wound healing. Offloading with pillow ...Dr. Reyes notified ...” During a review of Pt 18’s “Wound Care Subsequent Consult” dated 6/25/24, the “Wound Care Subsequent Consult,” indicated, “ ...Removed dressing from left posterior heel that continues to be an Unstageable ...” During a review of Pt 18’s “Wound Care Subsequent Consult” dated 7/23/24, the “Wound Care Subsequent Consult,” indicated, “ ...In to re-assess left heel ulcer which is now resolved with 100% re-epithelialization (replacement of lost or damaged epithelium - superficial pink/ white tissue that migrates across the wound from the wound margin, hair follicles or sweat glands). Cleaned with [Normal Saline] and left open to air ...” During a concurrent interview and record review on 7/23/24 at 11:00 a.m. with Director of Nursing (DON) 2 and wound nurse (WN) Pt 18’s “Electronic Health Record (EHR)” was reviewed. The WN stated he was familiar with Pt 18 and Pt 18 was still here admitted in the hospital. The WN stated he saw the patient for wound consult on 5/31/24 about left heel discoloration. The WN stated he had seen the patient few days prior but does not recall the exact date. The WN stated Pt 18 did not have any purple discoloring on the left heel few days prior to 5/31/24. The WN stated on 5/31/24 when he saw the patient, Pt 18’s left heel’s skin was intact and offloading (Heel offloading strategies include positioning pillows so that the heel is not touching the bed or using devices such as boots designed to completely suspend the heel when the patient is in bed) was in place. The WN stated no other interventions were needed at that time. The WN stated he documented the assessment on 5/31/24 at 12:00 p.m. The “Wound assessment,” by WN Indicated, “ ...Wound Bed Tissue Assessment: Purple Intact, Peri Would assessment Ecchymotic [brusing caused by broken blood vessels leaking into tissue]; Intact ... wound length 5 (centimeter - CM-unit of measurement) ... width 5 (cm).” The WN stated he took the picture and documented his assessment on 5/31/24. The WN stated he saw the patient after that on 6/10/24 and documented his assessment again. The “wound assessment” on 6/10/24 at 1600 p.m. by WN indicated, “ ...Wound Bed Tissue Assessment Sloughing; Intact ...Peri-Wound Assessment ...Intact Ecchymotic ...” The WN stated at that time he took the pictures, notified physician, received an order for wound care and worked with leadership to report pressure injury. The WN stated patient wound care and assessment was done by nursing staff on the unit between 5/31/24 and 6/10/24, the time from when the purple discoloration to unstable. During a concurrent interview and record review on 7/23/24 at 11:36 a.m. with DON 2 and WN Pt 18’s EHR was reviewed for wound assessment, skin assessment, and mobility section was reviewed for documented interventions to reduce pressure injury (sores, ulcers on skin that is under pressure) risk for Pt 18’s. The WN stated under mobility section heels would have documentation for interventions for offloading. The WN reviewed the documentation under mobility section for pressure relieving interventions for left heel for the dates of 5/29/24 until 6/10/24, a day before the finding of purple discoloration of left heel up until the left heel was documented to have unstageable pressure injury. The WN stated documentation was inconsistent. The WN stated many shifts no interventions were documented. The WN validated on 5/29/24 from 12:01 a.m. until 5/30/24 at 4:00 p.m. no documentation of offloading or pressure relief interventions were documented. WN stated without these interventions’ purple/discoloration can occur and without any documentation he was not able to tell if any interventions were in place. The WN stated this patient was high risk due to insulin dependent diabetes and already have a non-healing wound on right heel. WN then continued reviewing documentation for offloading or pressure relief interventions of left heel. WN stated no documentation in EHR was found for offloading or pressure relief interventions for left heel from 5/31/24 at 12:01 am to 5/31/24 at 4 p.m., from 6/1/24 at 12:01 a.m. till 6/1/24 at 7:00 a.m., from 8 to 12 p.m. on 6/2/24, from 6/5/24 at 6: p.m. to 6/6/24 at 7:00 a.m., from 6/6/24 at 10 p.m. to 6/7/24 at 2:00 a.m., from 6/8/24 at 4 p.m. to 10 p.m., from 6/8/24 at 10 p.m. to 6/9/24 at 8 a.m., from 6/9/24 at 6 p.m. to 6/10/24 at 8 a.m., from 6/11/24 at 8 a.m. to 4 p.m. WN stated these were the missed opportunities and per policy off-loading of left heel should have been done and documented every two hours. The WN stated potentially discoloration and progression of the wound to unstageable potentially could have been prevented if the appropriate pressure relieving interventions were in place. WN also reviewed all the wound pictures since admission on 5/19/24. WN stated after reviewing the picture that was taken on 6/2/24 that wound nurse should have been notified on 6/2/24. WN stated 5/31/24 to 6/10/24 was a long time in between wound nurse consult/assessment and WN should have been contacted sooner for follow up. During a concurrent interview and record review on 7/23/24 at 11:58 a.m. with DON 2, the DON 2 stated she validated with WN that no documentation was in EHR for pressure relieving interventions for left heel for the times mentioned by WN above. DON 2 stated staff failed to follow the policy and she expects that offloading was done every two hours for left heel. DON 2 stated she expects that staff is documenting interventions and if it was not documented, it was not done. DON 2 stated she also found documentation of wet to dry dressing change twice on left heel before 6/10/24 which was inaccurate as there was no order and wound was not open. DON 2 stated hospital policy highlights the importance of treatment plan to reduce the risk of pressure injury. DON 2 stated no pressure relieving interventions were documented for overnight after 6 pm on 6/9/24 until 8 a.m. on 6/10/24, the morning when the pressure injury was unstageable. DON 2 stated 14 hours was a long time for not having any pressure relieving interventions on left heel and could potentially cause pressure injury. During a review of the facility’s policy and procedure ( P&P) titled, “Skin breakdown and care of the patients with pressure injuries, incontinence associated dermatitis (IAD), and all wounds,” with the revise date of July 2022, the P&P indicated, “ ...Purpose: To promote healing, prevent the deterioration of exiting wounds, prevent new wounds and provide guidelines for assessment, prevention and treatment of skin breakdown ...Outcome: All skin breakdown, pressure injuries, wounds and inconsistence associated dermatitis (IAD) are assessed, staged if appropriate, documented, and treatment plan initiated to promote healing ...Deep Tissue Injury : Purple or marron localized area of discolored intact skin or blood -filled blister due to damage of underlying soft tissue from pressure and/or shear; the area may be preceded by tissue that is painful, firm, mushy, boggy, warmer or cooler as comparted to adjacent tissue ...Pressure Injuries ...proceed with treatment as follows ... Stage 1/Deep Tissue Injuries (with intact skin): Prevent skin breakdown and restore skin’s blood supply ...Relieve pressure and prevent shear and frictions ...Elevate extremity off of mattress, if applicable ... Apply heel/elbow protectors, if applicable ... Reduce Risks by ...Reliving pressure ...Reposition patient everyone to two hours and prn ... Alternate position even with small changes keeping patient slightly off affected area ...Ensure heels are free from pressure, use heel protectors if necessary, for reducing friction ...” During a professional reference review retrieved from (Greenwood C. Heel pressure ulcers: understanding why they develop and how to prevent them. Nurs Stand. 2022 Feb 2;37(2):60-66. doi: 10.7748/ns. 2021.e11740. Epub 2021 Dec 13. PMID: 34898093) titled, “Heel pressure ulcers: understanding why they develop and how to prevent them”, dated Feb, 2022, the reference indicated, “ ...Because of its anatomical location and the fact that it has no muscle or fascia and little subcutaneous tissue, the heel is highly vulnerable to pressure damage and pressure ulcer development. Heel pressure ulcers are often severe and challenging to heal. Heel pressure ulcers are caused by factors such as pressure, shear and friction and the vulnerability of the heel to pressure damage is increased by immobility, the patient’s skin status, the presence of previous pressure ulcers and/or scar tissue, and suboptimal tissue perfusion. The risk is also increased in patients with diabetes mellitus. The role of nurses includes assessing the risk and preventing the development of heel pressure ulcers ...” 49538 3. During a review of Pt 22’s “History and Physical (H&P),” dated 6/10/24, the H&P indicated, “ ...a 54 [year old] female ... Diagnosis/Indications for Procedure: ... Unspecified cirrhosis [a type of liver damage where healthy cells are replaced by scar tissue] of liver ... Other ascites [a condition in which fluid collects in spaces within your abdomen] ... Portal hypertension [high blood pressure in the portal vein that runs through your liver] ... Plan: [esophagogastroduodenoscopy (EGD- a procedure that allows the doctor to examine the inside of the esophagus (the hollow, muscular tube that passes food and liquid from your throat to your stomach), stomach, and first part of the small intestines )] ...” During a concurrent interview and record review on 7/23/24 at 9:45 a.m. with Practice Coordinator (PC) 1, Pt 22’s “Results Review,” dated 6/10/24 and electronic health record (EHR- a digital record of health information), dated 6/10/24 were reviewed. Pt 22’s “Results Review,” dated 6/10/24 at 1:15 p.m., indicated, Pt 22’s blood glucose was 33 mg/dL (normal value 70 to 100 milligrams per deciliter (mg/dL-unit of measure). PC 1 stated, Pt 22 was administered dextrose (a medication used to treat very low blood sugar) 12.5 grams (g-unit of measure). PC 1 stated, Pt 22 had her blood glucose checked after receiving dextrose. Pt 22’s “Results Review,” dated 6/10/24 at 1:38 p.m., indicated, Pt 22’s blood glucose was 86 mg/dL. Pt 22’s “Results Review,” dated 6/10/24 at 3 p.m., indicated, Pt 22’s blood glucose was 55 mg/dL. PC 1 stated, a blood glucose of 55 mg/dL was considered low. PC 1 stated, there was no documentation the anesthesiologist was notified of Pt 22’s blood glucose of 55 mg/dL. PC 1 stated, there was no documentation of nursing interventions completed to address Pt 22’s low blood glucose of 55mg/dL. Pt 22’s “Results Review,” dated 6/10/24 at 3:22 p.m., indicated, Pt 22’s blood glucose was 101 mg/dL. Pt 22’s EHR had no documentation of interventions performed to increase Pt 22’s blood glucose in 22 minutes. PC 1 stated, Pt 22 was discharged on 6/10/24 at 3:25 p.m. During an interview on 7/24/24 at 11:30 a.m. with anesthesiologist (MDA) 1, MDA 1 stated she performed a moderate sedation (a level of sedation in which a person is asleep but wakes when spoken to or touched) on Pt 22. MDA 1 stated, she was not notified of Pt 22’s blood glucose of 55 mg/dL on 6/10/24 at 3 p.m. MDA 1 stated, the licensed nurse should have notified her of any abnormal blood glucose levels, even if the patient had no symptoms. During an interview on 7/25/24 at 9:23 a.m. with Registered Nurse (RN) 1, RN 1 stated she was the recovery nurse for Pt 22. RN 1 stated, she did not document the interventions performed and provider notification for Pt 22’s low blood glucose level. RN 1 stated it was important to document the intervention performed to treat a low blood glucose to determine if the intervention was effective or not. During an interview on 7/25/24 at 9:45 a.m. with PC 1, PC 1 stated Pt 22 was stable to go home based on a scale used to determine when postsurgical patients can be safely discharged. PC 1 stated, Pt 22’s blood glucose was rechecked before discharge and “she was safe to go home.” PC 1 stated, she would not have kept Pt 22 another hour to check her blood glucose level. During a concurrent interview and record review on 7/29/24 at 10:42 a.m. with manager (MG) 1, the facility’s policy and procedure (P&P) titled, “Hyperglycemia/Hypoglycemia Treatment,” revised April 2024 was reviewed. The P&P indicated, “ ...PURPOSE: To establish guidelines to support the assessment, early recognition, and prompt intervention for the diabetic patients and/or patients with hyperglycemia and/or hypoglycemia ... DEFINITION: ... Hypoglycemia/Hypoglycemic: ... Blood glucose level less than 70 mg/dL with or without signs and symptoms of tachycardia, palpitation, sweating, nausea, tremor, headache, pallor, lightheadedness, mental status change, speech and/or motor dysfunction, visual disturbances, hunger, or emotional changes ... Licensed Independent Practitioner (LIP): Any Medical Providers, Advanced Practice Professionals, MD, DO, etc. with privileges at [name of hospital] ... PROCEDURE: ... See APPENDIX A for additional references ... After any intervention, notify the LIP of the patient’s condition, event, and current blood glucose ... Document treatment in electronic health record (EHR) under Medication Administration Record (MAR) and/or Intake/Output (I/O) ... APPENDIX A ... If blood glucose is below 70 mg/dL, patient is conscious, AND able to drink and swallow safely, notify the practice coordinator and treat for HYPOGLYCEMIA as follows: 1. Blood Glucose is 54-69 mg/dL, the patient is CONSCIOUS and is able to swallow: A. Treat with dextrose 15 gram/60mL oral solution -OR- 15g of glucose = ½ cup (4 ounces) apple juice or ½ cup (4 ounces) cranberry juice or ½ cup (4 ounces) reg, non-cola soda. B. Recheck the blood glucose every 15 minutes and repeat treatment based on glucose result up to a TOTAL of 3 attempts. C. Notify the LIP of the patient’s condition and blood glucose. D. Feed the patient a meal/snack according to hospital policy once blood glucose is GREATER than 69 mg/dL. E. Once the patient blood glucose exceeds 69 mg/dL, recheck it in one hour to ensure blood glucose has remained greater than 69 mg/dL. F. If hypoglycemia persists, contact the LIP for further orders. G. Document treatment in electronic health record (EHR) ...” MG 1 stated, he expected licensed nurses to follow the policy. MG 1 stated, he expected licensed nurses to notify the physician of a patient’s low blood glucose and document the notification in the EHR. MG 1 stated, he expected licensed nurses to document the treatment completed to treat a patient’s low blood glucose. During an interview on 7/30/24 at 12:18 p.m. with the Chief Nursing Officer (CNO), the CNO stated, she expected licensed nurses to follow the policy on hypoglycemia treatment. The CNO stated, licensed nurses should complete and document what treatment was done for low blood glucose. The CNO stated, licensed nurses should have notified the anesthesiologist when a patient has a low blood glucose. 4. During a review of Pt 23’s EHR dated 7/22/24, the EHR indicated, Pt 23 was a 52-year-old female whose primary language was Spanish. The EHR indicated, Pt 23 came to the facility for an outpatient colonoscopy (a procedure that lets your health care provider check the inside of your entire large intestine) due to hemorrhage (a loss of blood from a damaged blood vessel) of the anus (a loss of blood from a damaged blood vessel) and rectum (the last section of the large intestine). During a concurrent interview and record review on 7/23/24 at 2:20 p.m. with Practice Coordinator (PC) 1, Pt 23’s EHR, dated 7/22/24 was reviewed. PC 1 stated, Pt 23 arrived in the facility on 7/22/24 at 8:27 a.m. and was placed in the pre-procedure (prior to a surgical or medicinal procedure) bed at 8:36 a.m. PC 1 stated, Pt 23 was placed in the procedure room at 11:19 a.m. PC 1 stated, Pt 23 did not have vital signs (blood pressure, heart rate/rhythm, respiratory rate, oxygen saturation) or pain assessment completed prior to the procedure. PC 1 stated, it was important to complete vital signs and pain assessment prior to a procedure to know what the patient’s baseline vital signs and acceptable pain level was. PC 1 stated, she expected licensed nurses to complete vital signs and pain assessment prior to a procedure. During an interview on 7/29/24 at 10:50 a.m. with Manager (MG) 1, MG 1 stated, he expected licensed nurses to complete a baseline vital signs. MG 1 stated, it was important to complete baseline vital signs to have a foundation of a patient’s clinical status and to understand changes that happened during the procedure. During an interview on 7/30/24 at 12:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated, she expected licensed nurses to complete baseline vital signs prior to a procedure. The CNO stated, baseline vital signs was important to know the patient’s norm and to determine when treatment was needed. During a review of the facility’s policy and procedure (P&P) titled, “Sedation/Analgesia, Moderate,” revised September 2023, the P&P indicated, “ ...PURPOSE: To ensure that moderate sedation/analgesia for procedures is administered safely and consistently through the [name of hospital] ... OUTCOME: Patients receiving moderate sedation/analgesia for procedures resume their baseline status ... GENERAL INFORMATION: ...This policy is in effect whenever moderate sedation/analgesia is used, which may include but is not limited to: ... Endoscopic procedures ... Imaging procedures requiring moderate sedation/analgesia ... PROCEDURE: ... RN completes the following: ... Pre-Procedure Systems Assessment ... Verifies: ... Age and weight ...Planned procedure ...Allergies ...Current Medications ...NPO status ...Consent for procedure ...Pre-procedure level of consciousness ...Baseline vital signs; [blood pressure], heart rate/rhythm, respiratory rate, oxygen saturation ... Post Procedure: ... The recovery of the patient is continuously supervised by a qualified RN ...” During a review of the facility’s policy and procedure (P&P) titled, “Documentation, Endoscopy,” revised December 2020, the P&P indicated, “ ...Day of Procedure Information ... Vital signs ... Adult physical assessment ...” 5. During a concurrent interview and record review on 7/23/24 at 2:45 p.m. with Practice Coordinator (PC) 1, Pt 23’s “After Visit Summary (AVS),” dated 7/22/23 was reviewed. PC 1 stated, the AVS had the home care instructions written in English. PC 1 stated, the home care instructions had a Spanish written version, and the Spanish version should have been used for Pt 23. PC 1 stated, it was important to provide discharge instructions in Spanish to Pt 23 so that she would understand how to care for herself at home. During a phone interview on 7/25/24 at 5:42 p.m. with Pt 23 and family member (FM) 1, Pt 23 stated she understood “a little English” and asked for FM 1 to translate. Pt 23 stated, discharge instructions in Spanish was preferred. During an interview on 7/30/24 at 12:24 p.m. with the Chief Nursing Officer (CNO), the CNO stated, she expected discharge instructions to be given in Spanish for patients whose primary language was Spanish. The CNO stated, it was important to provide Spanish discharge instructions so the patient could understand it. During a review of the facility’s policy and procedure (P&P) titled, “Discharge Planning,” revised June 2020, the P&P indicated, “ ...PURPOSE: To outline the process for planning continuing care, treatment and services to meet the needs of the patient and the patient’s family during and after the hospital stay ... POLICY: ... Consideration will be given to the learning needs/knowledge deficit of the patient and the patient’s family regarding their follow-up care, treatment and services needed ... Communication: ... To ensure continuity of care among settings, organizations and providers, appropriate patient information is communicated when patients are admitted, referred for consultation or treatment or discharged ... Written discharge instructions are provided, in a form the individual can understand, to all individuals and organizations, including family members, community organizations or other care providers responsible for the patient’s care ...” During a review of the facility’s policy and procedure (P&P) titled, “Limited English Proficiency (LEP): Interpreter and Communication Aids,” revised November 2023, indicated, “ ...OUTCOME: Patients who are vision, speech, physical and hearing impaired, or have Limited English Proficiency (LEP) are offered communication assistance during the delivery of all significant healthcare services ... DEFINITIONS: ... Limited English Proficiency (LEP): Individuals who do no speak English as their primary language or have a limited ability to read, write, ,speak, or understand English ... High Risk Communication: This healthcare administrative, medical, and clinical communication requires a high degree of certainty that the patient fully understands the information and has an opportunity to ask questions related to the information provided. These vital documents provided by a certified medical translation service may include but are not limited to: ... Informed consent for procedures ... Discharge instructions ... POLICY: ... Certified interpreting services will be offered and made available whenever a LEP, language, or communication barrier exists ... For High-Risk Communication: ... The Language Line or other certified, contracted, and appropriate language service will be used ...” 6. During a review of Pt 24’s EHR dated 7/22/24, the EHR indicated, Pt 24 was a 37-year-old female who came to the facility for an outpatient EGD due to gastroesophageal reflux disease (GERD- when acid from your stomach backs up into your esophagus) without esophagitis (inflammation of the esophagus). During a concurrent interview and record review on 7/23/24 at 3:35 p.m. with Practice Coordinator (PC) 1, Pt 24’s EHR was reviewed. PC 1 stated, Pt 24 entered “Phase II” (focuses on preparing patients for hospital discharge, including education regarding the surgeon’s postoperative instructions and any prescribed discharge medications) on 7/22/23 at 1:42 p.m. PC 1 stated, Pt 24 did not have an assessment completed when Pt 24 entered “Phase II”. PC 1 stated, the recovery nurse should have completed an assessment and expected the recovery nurse to complete an assessment when the patient entered “Phase II” per facility policy. During a review of Pt 25’s EHR, the EHR indicated, Pt 25 was a 69-year-old male who came to the facility for an outpatient endoscopic ultrasonography (a procedure to examine the inside of your digestive tract) due to abnormal weight loss. During a concurrent interview and record review on 7/24/24 at 1:40 p.m. with PC 1, Pt 25’s EHR dated 7/22/24, was reviewed. PC 1 stated, Pt 25 entered “Phase II” on 7/22/24 at 2:25 p.m. PC 1 stated, Pt 25 did not have an assessment completed when Pt 25 entered “Phase II”. PC 1 stated, Pt 25 should have had an assessment completed at 2:25 p.m. During an interview on 7/29/24 at 10:55 a.m. with manager (MG) 1, MG 1 stated he expected licensed nurses to assess a patient “immediately in recovery.” MG 1 stated, he expected a patient to be assessed per the facility’s P&P. During an interview on 7/30/24 at 12:22 p.m. with the Chief Nursing Officer (CNO), the CNO stated, she expected licensed nurses to complete an assessment in the recovery phase then periodically. During a review of the facility’s policy and procedure (P&P) titled, “Documentation, Endoscopy,” revised December 2020, the P&P indicated, “ ...Post Procedure ... Assess patient immediately upon arrival to the recovery area ... Assessment includes, but is not limited to: ...Suctioning ...Status of abdomen ...Nausea and/or vomiting present ...Surgical/procedural site condition ...Refer to Pre procedure assessment ... Document in PACU View ...Vital signs ...Pain/Comfort ...Aldrete I ...Oxygen administration ...PACU assessment ...Aldrete II ...PACU Discharge ... Document in physical assessment ... Neurological assessment ... Mental status ... Respiratory assessment ... Cardiovascular assessment ... Gastrointestinal assessment ...” During a review of the facility’s policy and procedure (P&P) titled, “Sedation/Analgesia, Moderate,” revised September 2023, the P&P indicated, “ ...PURPOSE: To ensure that moderate sedation/analgesia for procedures is administered safely and consistently through the [name of hospital] ... OUTCOME: Patients receiving moderate sedation/analgesia for procedures resume their baseline status ... GENERAL INFORMATION: ...This policy is in effect whenever moderate sedation/analgesia is used, which may include but is not limited to: ... Endoscopic procedures ... Imaging procedures requiring moderate sedation/analgesia ... PROCEDURE: ... [Registered Nurse (RN - provide and coordinate patient care, educate patients and the public about various health conditions, and provide advice and emotional support to patients and their families)] completes the following: ... Pre-Procedure Systems Assessment ... Verifies: ... Age and weight ...Planned procedure ...Allergies ...Current Medications ...[nothing by mouth (NPO- avoid food and drink for hours before your medical or surgical procedure)] status ...Consent for procedure ...Pre-procedure level of consciousness ...Baseline vital signs; [blood pressure], heart rate/rhythm, respiratory rate, oxygen saturation ... Post Procedure: ... The recovery of the patient is continuously supervised by a qualified RN ... The recovery consists of an initial assessment followed by a minimum of two, every fifteen-minute assessments ...” 7. During a review of Pt 27’s “History and Physical (H&P),” dated 7/16/14, the H&P indicated Pt 27 was a 28-year-old female, gravida (the total number of confirmed pregnancies that a female has had) 1, para (the number of births that a female has had) 0 at 34 weeks and 6 days gestation (the process or period of developing inside the womb between conception and birth). Pt 27 was admitted for pregnancy-induced hypertension (PIH-a form of high blood pressure in pregnancy), preeclampsia (high blood pressure and signs of liver or kidney damage that occur in women after the 20th week of pregnancy), and intrauterine growth restriction (IUGR-the poor growth of a baby while in the mother’s womb during pregnancy). During a concurrent interview and record review on 7/26/24 at 11:15 a.m. with Practice Coordinator (PC) 2, Pt 27’s “EHR” and “Flowsheets, LDA and Wound Assessments (FLDAWA),” dated 7/21/24, 7/24/24 and 7/25/24 were reviewed. PC 2 stated, Pt 27 delivered via cesarean section (C/S- the surgical delivery of a baby through a cut made in the birth parent’s abdomen and uterus) on 7/21/24 at 4:37 a.m. and was transferred to Postpartum on 7/21/24 at 8:07 a.m. PC 2 stated, Pt 27’s wound incision was not assessed when Pt 27 was transferred to the Postpartum unit. PC 2 stated, Pt 27’s wound incision was first assessed on 7/21/24 at 8:20 p.m. a time lapse of 12 hours after transfer to postpartum. PC 2 stated, Pt 27’s wound incision was not assessed from 7/24/24 at 8:52 a.m. to 7/25/24 at 8:30 a.m. (a time lapse of 24 hours after the last assessment). During a review of Pt 28’s “H&P,” dated 7/22/24, the H&P indicated, Pt 28 was a 29-year-old female, gravida 2, para 1 at 40 weeks gestation. The H&P indicated, Pt 28 was admitted for a repeat C/S. During a concurrent interview and record review on 7/26/24 at 12 p.m. with PC 2, Pt 28’s “EHR” and “FLDAWA,” dated 7/22/24, 7/23/24 and 7/24/24 were reviewed. PC 2 stated, Pt 28 delivered via C/S on 7/22/24 at 8:05 a.m. and was transferred to Postpartum on 7/22/24 at 11:12 a.m. PC 2 stated, Pt 28’s wound incision was assessed on 7/22/24 at 11:25 a.m. and the next assessment was completed at 9:57 p.m. (a time lapse of 10 hours and 32 minutes). PC 2 stated, Pt 28’s wound incision was not assessed on the day she was discharged from the facility on 7/24/24 at 3 p.m. PC 2 stated, Pt 28’s wound incision was last assessed on 7/23/24 at 8:15 p.m. (a time lapse of 19 hours from the last assessment) During an interview on 7/26/24 at 3:15 p.m. with manager (MG) 3, MG 3 stated a patient who had a cesarean section a surgical delivery of a baby, should have the wound incision assessed on admission to Postpartum to document the patient’s baseline and every four hours for the first 24 hours after a C/S. MG 3 stated, the wound incision should be assessed each shift and she expected licensed nurses to assess the wound incision each shift. MG 3 stated, it was important to assess the wound incision to make sure there was no dehiscence (when a surgical incision reopens), redness, swelling, or discharge that would indicate an infection. MG 3 stated, licensed nurses should be following the facility’s policy. During an interview on 7/30/24 at 12:28 p.m. with the Chief Nursing Officer (CNO), the CNO stated, she expected wound incision assessment be completed per the facility’s P&P. The CNO stated, an assessment of the wound incision should be completed each shift to identify changes in wound condition. During a review of the facility’s policy and procedure (P&P) titled, “Postpartum Care,” revised September 2023, the P&P indicated, “ ...PURPOSE: To provide guidelines for nursing staff when caring for the patient and her family during the postpartum period ... PROCEDURE ... Incision ... Assess incision upon arrival to mother-baby unit, then [every] 4 hrs. for first 24 hrs., then [every] shift ...” 8. During a review of Pt 27’s “History and Physical (H&P),” dated 7/16/14, the H&P indicated Pt 27 was a 28-year-old female, gravida (the total number of confirmed pregnancies that a female has had) 1, para (the number of births that a female has had) 0 at 34 weeks and 6 days gestation (the process or period of developing inside the womb between conception and birth). Pt 27 was admitted for pregnancy-induced hypertension (PIH-a form of high blood pressure in pregnancy), preeclampsia (high blood pressure and signs of liver or kidney damage that occur in women after the 20th week of pregnancy), and intrauterine growth restriction (IUGR-the poor growth of a baby while in the mother’s womb during pregnancy). During a concurrent interview and record review on 7/26/24 at 11:30 a.m. with Practice Coordinator (PC) 2, Pt 27’s “Informed Consent,” dated 7/21/24 was reviewed. PC 2 stated, Pt 27’s primary language was Spanish. PC 2 stated, an interpreter was not utilized and documented per the facility’s P&P. PC 2 stated, an interpreter should have been used to ensure Pt 27 understood the procedure she was having, and the risks and benefits associated with the procedure. PC 2 stated, she expected licensed nurses to utilize an interpreter and document the use of an interpreter. During an interview on 7/30/24 at 12:26 p.m. with the Chief Nursing Officer (CNO), the CNO stated, she expected licensed nurses to use the hospital’s interpreting service for all consents. The CNO stated, it was important to provide information to patients in a language they understood so they could make an informed decision. During a review of the facility’s policy and procedure (P&P) titled, “Informed Consent/Consent Forms,” revised August 2023, the P&P indicated, “ ...PURPOSE: To provide information to the patient regarding their health status, diagnosis, prognosis and appropriate care, treatment and services options allowing the patient to make an informed choice, as well as, to provide guidelines for completing and witnessing consent forms ... PROCEDURE ... The physician informs the patient (or persons legally authorized to make health care decisions on the patient’s behalf) about the treatment or procedure, possible risks, complications, expected benefits and feasible alternatives ... GENERAL INFORMATION ... If the patient is unable to speak, read or understand English, interpreter services must be available to explain the consent form to the patient ...Personnel witnessing the patient’s signature documents, with a written explanation stating that the consent form was interpreted for the patient by Interpreter’s name/number ...” During a review of the facility’s policy and procedure (P&P) titled, “Limited English Proficiency (LEP): Interpreter and Communication Aids,” revised November 2023, indicated, “ ...OUTCOME: Patients who are vision, speech, physical and hearing impaired, or have Limited English Proficiency (LEP) are offered communication assistance during the delivery of all significant healthcare services ... DEFINITIONS: ... Limited English Proficiency (LEP): Individuals who do not speak English as their primary language or have a limited ability to read, write, ,speak, or understand English ... High Risk Communication: This healthcare administrative, medical, and clinical communication requires a high degree of certainty that the patient fully understands the information and has an opportunity to ask questions related to the information provided. These vital documents provided by a certified medical translation service may include but are not limited to: ... Informed consent for procedures ... Discharge instructions ... POLICY: ... Certified interpreting services will be offered and made available whenever a LEP, language, or communication barrier exists ... For High-Risk Communication: ... The [name of interpreting services] or other certified, contracted, and appropriate language service will be used ...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 49230 Based on interview and record review, the hospital failed to ensure registered nurses (RNs) administered insulin in accordance with physician orders for one of the three sampled patients, Patient [Pt] 19 when Registered Nurses administered insulin continuous intravenous drip (the administration of a fluid into a blood vessel, usually over a prolonged period of time) for Pt 19 to treat hyperglycemia and the insulin dose rate was not titrated in accordance with the physician medication order of Insulin Algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) despite being verified by two nurses. Pt 19 had the potential for ineffective blood glucose (BG) management and received incorrect doses. This failure resulted in not providing the medication as ordered by the physician and placed patient at risk of harm, and/or adverse outcomes. Findings: During a review of Pt 19’s “CCH Hospitalist H&P” dated 7/18/24, the “CCH Hospitalist H&P” indicated, Pt 19 was a 71 year old male with significant history of unspecified Congestive heart failure (CHF - a long-term condition that happens when your heart can not pump blood well enough to give your body a normal supply), hypertension (high blood pressure), Coronary artery disease (CAD - condition which limits blood flow in your coronary arteries, which deliver blood to your heart muscle) with prior stenting (a small metal tube that is used to unblock a coronary artery), borderline diabetes (a chronic disease that occurs either when the body does not produce enough insulin or when the body cannot effectively use the insulin it produces). Patient presented to the emergency room with chief complaint of generalized weakness and intermittent dizziness/light headedness without syncope (passing out). 12 lead Electrocardiogram (EKG - test to record the electrical signals in the heart) showed A-fib (An irregular, often rapid heart rate that commonly causes poor blood flow) and patient was admitted to Telemetry (is a floor in a hospital where patients undergo continuous cardiac monitoring) and underwent Coronary artery bypass grafting (heart bypass surgery, is a medical procedure to improve blood flow to the heart). During a review of Pt 19’s physician “Medication Orders” dated 7/22/24, the “Medication Order” for insulin indicated, “ ...insulin regular ...ordered dose: 0-20 units (unit of measurement)/[hour - (hr - unit of time)] Route: Intravenous Frequency: Continuous[at] 0-20 [milliliter (ml -unit of measurement)] /hr ...Admin instructions: GOAL EFFECT: BG range 140-170 [milligram (mg-unit of measurement) per deciliter (dL- unit of measurement of volume)]. Titration per insulin calculator ...Check BG hourly when initiating insulin infusion ...” During a concurrent interview and record review on 7/26/24 at 1:27 p.m. with the Director of Critical Care (DON 3), Health Informatics 1 & Manager of Cardiovascular Intensive Care Unit (MG 7) Pt 19’s medical record was reviewed. The “Medication Administration Record (MAR)” in medical record dated 7/22/24 to 7/24/24 for insulin administration indicated Pt 19 was started on the insulin continuous intravenous on 7/22/24 at 9:15 a.m. at the dose rate of 1 unit/hr. The MAR indicated Pt 19’s insulin dose rate was changed to 0 units/hr on 7/23/24 at 9:08 p.m. and insulin was held until the order was stopped on 7/24/24 at 10:59 a.m. The MAR and electronic health record (EHR) did not indicate starting BG level and order for starting dose of 1 unit/hr. The MG 7 stated she was not able to find any documentation of BG or reason for starting the dose rate at 1 units/hr in EHR. MG 7 stated insulin was started in Operating room (OR) on 7/22/24 at 9:15 a.m. at 1units/hr and first dose rate change at 10:03 a.m. was also done in the OR. The dose rate was increased on 7/22/24 at 10:03 a.m. to 2 units/hr. MG 7 stated she was also unable to find any documentation of BG or physician order to support the first dose rate change. MG 7 stated after that patient arrived in Cardiovascular Intensive Care Unit (CVICU -Unit specializes in the care of critically ill patients with heart and vascular problems) and first BG check in CVICU was done at 10:43 indicating BG level of 171 and dose rate was changed to 0 units/hr. The MG 7 stated BG results upon arrival to CVICU on 7/22/24 was 171 and the dose rate for insulin should have remain unchanged at 2 units/hr per insulin infusion calculator as the goal was BG range 140-170 mg/dl instead of changing rate to 0 units/hr. The Insulin infusion dose rate remained at 0 units/hr and intravenous insulin remained off on 7/22/24 from 10:48 a.m. until 2:13 p.m. when it was restarted at 2 units/hr. MG 7 stated the dose rate change to 0 units/hr on 7/22/24 at 10:48 was an error. MG 7 state RN selected action “INITIATE” instead of “CONTINUE” therefore the calculator was using initiation formula instead of continuing rate calculation on insulin that was already infusion. MG 7 stated 12:00 p.m. and 1:00 p.m. BG results were not added in the MAR. MG 7 stated without accurate rate change action on 7/22/24 at 10:48 and not having documentation of subsequent BG level in MAR, the insulin infusion calculator was not calculating the correct dosage. MG 7 did the manual calculation using the insulin algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) and validated the starting dose and subsequent changes at 10:48 a.m. until 2:13 p.m. were not done correctly. MG 7 stated that she was unable to validate any subsequent dose rate would be accurate as the starting dose rate was not correct and subsequent BG were not entered in MAR. MG 7 stated insulin dose rate was changed four times on 7/22/24 after the initial dose rate of 0 units/hr at 10:48 a.m. and dose rate was changed eight times on 7/23/27 before insulin infusion was stopped. MG 7 stated BG results were not consistently documented every hour or as needed in MAR calculator and were required to calculate the next correct dose rate. MG 7 stated initial rate change in CVICU on 7/22/24 at 10:48 a.m. was incorrect and this would impact all subsequent 12 dose rate changes as they may not be calculated right. MG 7 stated she would need to review this with Medication Safety Pharmacist (MSP). During a concurrent interview and record review on 7/26/24 at 2:00 p.m. with the MSP, Pt 19’s MAR and EHR for the hospital visit of date 7/18/24 was reviewed for the insulin administration. The MSP stated it appears that the insulin was not started at the correct dose upon arrival to CVICU as the “INTIATE” function was selected instead of “continue”. The MSP stated subsequent dose rate adjustments would not be correct if the BG results were not entered in the MAR every hour or as required per infusion administration guidelines. The MSP stated he would have to go back and figure this out using manual calculation. The MSP stated the dose rate changes does not add up and it appears an error was made during adjustments. The MSP stated the insulin titration does not align with physician “Medication order” for insulin. During a concurrent interview and record review on 7/26/24 at 2:15 p.m. with the MG 8, Pt 19’s MAR and EHR for the hospital visit of date 7/18/24 were reviewed for the insulin administration. MG 8 stated she was not able to validate with manual calculation using insulin algorithm that dose rate adjustments made utilizing the infusion dose calculator were correct. MG 8 stated she would need to work with MSP and MG7 to figure out the errors. During an interview on 7/29/24 at 8:30 a.m. with the Director of Quality (DQ), the DQ stated after the chart review on 7/26/24 at 1:27 p.m. team have identified gaps and acknowledged that the RNs failed to follow policies or protocol. The DQ submitted a plan of correction which indicated corrective action hospital placed on the 7/26/24 after identifying gaps. The DQ stated the registered nurses (RNs) did not document and should have documented the blood glucose (BG) level within the Medication Administration Record (MAR) hourly. The DQ stated the RNs thought the BG was pulled automatically from point of care testing (POCT - is clinical laboratory testing conducted close to the site of patient care where care or treatment is provided) and other lab tests such as chemistry panel (blood tests that measure amounts of certain chemicals in a sample of blood) or ABG (measures the balance of oxygen, carbon dioxide and acid base balance in blood). The DQ stated failure to document the BG results hourly in MAR resulted in an incorrect infusion dose since the dosing calculation is based on the last documented BG in MAR which could be hours prior and not the last hour BG result as it was not documented. The DQ stated in addition RNs did not select appropriate action in calculation for initiation versus rate change which resulted in incorrect calculation which further led to incorrect dosing of insulin. The DQ stated this was significant failure and had the potential to harm patients. The DQ stated staff education and retraining was started immediately to avoid any harm to the patients. During an interview on 7/29/24 at 9:53 a.m. with DON 3 & MG 7, DON3 stated after the record review on 7/26/24 at 1:27 p.m. they have been working on educating and retraining nursing staff. DON 3 stated they submitted the corrective action plan to DQ. The corrective plan that was submitted by DQ was something that DON3 and MG 7 worked on for the gaps identified during record review. DON 3 stated nursing staff was not following the correct process for documenting the blood glucose every hour on the MAR. The DON 3 stated they were not aware the MAR does not pull BG value automatically from within the electronic health record (HER). DON 3 stated this led to incorrect dosing as the calculator was using the last inputted value as oppose the newest BG that was not entered. DON 3 stated staff was also selecting wrong action in calculator initiate versus continue. DON 3 stated each action have different formula for calculations and by selecting wrong action, it led to errors in dosage calculation. During a review of the facility’s “plan of correction (POC)” dated 7/26/24, the POC indicated, “ ...[Hospital name] acknowledges we did not follow our internal policies or protocol orders for patient [19]. The following is what should have occurred in for the care of patient and contributing factors ...The RN should have documented the blood glucose (BG) Level with in the Medication Reconciliation Administration (MAR) hourly, especially in the “Enter Protocol Action and Current POC Blood Glucose” ...RN thought the BG was pulled in from POCT, ABG, and/or chemistry ...failure to document the BG results hourly in the MAR will result in an incorrect infusion dose since the dosing calculations is based on the last documented BG in the MAR (which could be hours prior and not the last BG result required for the current infusion rate change) ...Additionally, the RN did not select the appropriate action of initiated verses rate change which results in an incorrect calculation which would lead to an inappropriate dosing of insulin ... The provider should not have adjusted the BG goal range, the two- options available to the provider from Yale insulin infusion calculator include either a goal rage is 120-170 or 140-180 (at this time, there does not appear to be an [EHR] warning/[Best practice advisory]BPA/hard stop when provider changes this BG Goal Range, however, despite doing this calculator will only keep the setting of original order) ...if a different BG goal range is desired by the provider, then they should consult with Pharmacy for a more appropriate insulin drip titration order to meet their BG range ...” During a review of the facility’s “policy and procedure (P&P)” titled, “Medication policies”, Date reviewed February 2023, P&P indicated “ ...1. Patients receive medications according to physician oders ...8. When ordering titratable IV medications, the prescriber will indicate the starting dose, titration frequency, titration dose, goal parameters, the maximum dose, and when to call the prescriber...Licensed nursing staff will use the “five rights”: the right patient, the right drug, the right dose ...The Right Dose: Check the medication order and the appropriateness of the drug. If necessary, then calculate the dose and have another clinician calculate the dose as well.””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 49230 Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when: 1.Hot lab room (rooms in nuclear medicine hospitals that have been specially designed to deliver, store, and prepare radioactive materials) walls had rough surface with black stains and paint chipped above and around the radiopharmaceuticals (radioactive agents that are used to help diagnose certain medical problems, only small amounts are given to the patient) storage. The Hot lab patient nourishment refrigerator inside flooring had brown deposits, yellow stains and was stocked with expired boxes of the orange juices. These findings had the potential of cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and the potential risk for infections in patient receiving nuclear image (radiopharmaceuticals are taken internally, for example, through inhalation, intravenously, or orally. Then, external detectors capture and form images from the radiation emitted by the radiopharmaceutical) testing at the facility. 2.Used Transesophageal echocardiogram (TEE) probes (A thin, flexible tube-like instrument with a probe like a microphone which sends out ultrasonic sound waves used to look at tissues inside the body, usually done by inserting a probe with a transducer down the esophagus) were being cleaned in a ultrasound (sound waves to make pictures of organs, tissues, and other structures inside your body)/ Electro Cardio Gram - (ECG a test to record the electrical signals in the heart area) testing room in between patients, without the room being clean in between scopes cleaning and the next patient testing. This failure had the potential for exposure and transmission of diseases to every patient receiving testing after the probes were cleaned. 3.Cardiovascular Operating Room (CVOR) satellite pharmacy (decentralized operating unit which has similar function with the central inpatient pharmacy) flooring had a hole with chunk of floor missing inside the sterile compounding (custom made -pharmaceutical preparation) area. The hole was approximately one inch deep and about two inches wide and appear to have dust particles in the hole. The flooring could not be disinfected in accordance with professional standards and had the potential to allow bacteria to harbor in the cracked and chipped surfaces and lead to patient infection. As a result of these failures, all patients and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections. Findings: 1. During a concurrent observation and interview on 7/22/24 at 2:44 p.m. with Director of Nursing (DON) 1, DON 2 & Nuclear Medicine Technician (NMT) 1 in the Hot lab room, noticed the back wall above the Radiopharmaceuticals ( radioactive agents that are used to help diagnose certain medical problems, only small amounts are given to the patient) storage in the room with black stains, paint chipping off and rough surface approximately 3 feet long and 2 feet wide. The second wall next to laminar flow hood (environment for the preparation of medication. These hoods work by filtering air through a high-efficiency particulate air (HEPA) filter, which removes particles and contaminants, including bacteria, viruses, and fungi, from the air) also had black stain, rough surface with paint chipping off. The wall behind eye wash station had shelf falling off from one side with holes that appears to where the shelf was screwed. The eye wash station was observed with white crusty deposits on the pipe. The patient nourishment refrigerator in Hot lab room was inspected next. The patient nourishment refrigerator had brown deposits and yellow stains all inside all over on the refrigerator floor. The refrigerator also had two boxes of orange juice, and both had expiration date of 2/11/24. The NMT stated Hot lab was secured area and only NMTs have access to it. The NMT stated she coordinates with the environment services (EVS) team and supervises them while the EVS team completes cleaning of the lab area. The NMT agreed that walls need cleaning and repair. The NMT stated currently the walls are not wipeable and rough surface could be a potential to Harbor germs and cause cross contamination. The NMT stated their focus always was on Radiopharmaceutical safety and did not submit work order for repairs. The NMT stated the walls have been in these condition needing repair for at-least last ninety days. The NMT stated the patient refrigerator needs cleaning and brown deposits were spilled juices. The NMT stated unable to comment on expired juices, but it should not be in patient refrigerator. The NMT stated EVS always have one of the NMTs supervising them and she was unsure how these items were missed. During a concurrent observation and interview on 07/22/24 at 2:50 p.m. with the Manger of Imaging (MI) in the Hot lab room, the MI stated he was the manger over the nuclear medicine and hot lab area. MI stated he does not routinely round in the Hot lab room. The MI stated last time he was in the Hot lab room was during the last survey, more than three months ago. The MI stated he was unable to tell what the black deposits/stains were on the walls in the hot lab room, and it could be a potential for cross contamination. The MI stated his staff failed to submit work orders for repair and he expects no paint chips, cracks or holes in the walls that could be potential source for cross contamination. The MI then looked at the patient nourishment refrigerator and stated, “it looks dirty and not acceptable”. The MI stated he would immediately work with his leadership team to repair the integrity of the walls, get eye wash station clean and clean patient nourishment refrigerator. The MI discarded the two expired juice boxes. The MI stated expired items are not safe for patients and could lead to infections. During a concurrent observation and interview on 7/22/24 at 2:53 p.m. with DON 1 in the Hot lab room, DON 1 stated the condition of both walls needs repairs and could be a potential source for infection. DON 1 stated the refrigerator floor “definitely needs cleaning” and patient nourishment refrigerator should never be stocked with expired food product. The DON 1 stated potential risk for expired food reaching to the patient and causing harm to the patients. During a concurrent observation on 7/23/24 at 9:09 a.m. with the Director of Patient Safety (DPS) in the Hot lab room, the DPS stated the walls needs cleaning and repair to avoid any potential for cross contamination. The DPS stated no expired product should be stored in patient nourishment refrigerator and surface areas in refrigerators must be kept clean to avoid any cross contamination. The DPS stated important for patient safety to ensure all food items are kept at appropriate temperature and used before expiry date. The DPS agreed potential for harm with expired food products if products are consumed by patients. During a concurrent observation on 7/23/24 at 9:15 a.m. with the Director of Infection Prevention (DIP) in Hot lab room, the DIP stated she was aware of the observation from yesterday. The DIP stated the Hot lab wall area above storage of pharmaceuticals should have been a wipeable surfaces. The DIP stated bacteria can harbor in cracks, chipped area and create a risk for cross contamination. The DIP stated she was not able to comment on what the black stains/deposits on the walls were but stated it was not acceptable and does not meet IP expectations. The DIP stated the refrigerator with patient food should be kept clean and any deposits, stains, and spills inside should be clean routinely. The DIP stated it is important to remove expired food products from the patient care areas to avoid the risk of patient received expired food items that can lead to harm in patients. During an interview on 7/23/24 at 9:20 a.m. with the MI, the MI stated he submitted the work orders yesterday after the observation on 7/22/24 at 2:50 p.m. and the facilities team already have a plan to repair walls as soon as possible. The MI stated the patient refrigerator has been cleaned. The MI stated historically he only rounded in the Hot lab room during surveys but going forward he will routinely round to ensure the environment is safe. The MI stated there was “absolutely no reason why the lab looked like this and had expired items in patient nourishment refrigerator.” During an interview on 7/30/24 at 12:16 p.m. with the Chief Nursing Office (CNO), the CNO stated the walls in the Hot lab room needed repair and had the potential risk for cross contamination. The CNO stated we follow safe food handling practices, and it was never ok to have expired product in patient nourishment areas. The CNO stated the refrigerator observation on 7/22/24 at 2:44 p.m. bottom floor inside the refrigerator looks “ugly”, potential for infection and not acceptable in hospital settings. The CNO Stated she expects staff members are filling out work order and notifying leadership for any repair needed in their areas. The CNO stated she also expects staff is routinely checking for expired items and removing it. 2. During a concurrent observation and interview on 7/22/24 at 3:31 p.m. with DON 1 & Registered Diagnostic Cardiac Sonographer (RDCS - specialized kind of cardiovascular technologist who focuses on using ultrasound ( sound waves to make pictures of organs, tissues, and other structures inside your body) equipment to image a patient’s heart) 1 in the Cardio Vascular Diagnostic Services (CVDS) department in ultra sound testing room number two, right next to sink, noticed two transesophageal echocardiogram (TEE) probes (A thin, flexible tube-like instrument with a probe like a microphone which sends out ultrasonic sound waves used to look at tissues inside the body, usually done by inserting a probe with a transducer down the esophagus) being set up for pre- clean. The sink had an open [brand name] beside pre- clean kit being filled with water and sponge inside. The RDCS stated that their team use this room two for pre cleaning of all TEE probes after being used on patients on different floor. The RDCS 1 stated majority of the TEE procedures are completed on a different floor in a dedicated procedure room in Cardiovascular Recovery Area. The RDCS 1 stated after the procedure is complete, their process was to bring the TEE probes down to room two and pre clean it before taking it down to Sterile Processing Department (SPD- is the area in a hospital where cleaning and sterilization of devices used in medical procedures takes place). The RDCS 1 stated room two gets used for Ultrasound /Electro Cardiogram (ECG- a test to record the electrical signals in the heart) testing and their team will clean TEE probes in between scheduled patients for ultrasound and ECG. The RDCS stated usually they see six to eight patients daily in the room two where they clean their probes in between seeing patients. The RDCS 1 stated this process of cleaning TEE probes in the ultrasound room 2 in between seeing patients for testing or ECG has been ongoing for almost a year. The RDCS 1 stated the room does not get terminally (a procedure required to ensure that an area has been cleaned/decontaminated) clean after the used probes are pre cleaned in the room’s sink and prior to seeing next patient in that room. The RDCS 1 stated throughout the day they bring probes down in between patient’s testing in ultrasound room two to do the pre cleaning. The RDCS 1 stated he does not foresee any concerns with pre cleaning the used probes in the testing rooms in between patients without the room being cleaned after pre cleaning scopes and seeing the next patient. During a concurrent observation and interview on 7/22/24 at 3:35 p.m. with DON 1 in the CVDS department in ultrasound testing room number two, the DON 1 stated she was the director for the CVDS department. The DON 1 stated she was going to “re-look at the workflow with the department leadership team”. The DON 1 stated she can understand the risk for cross contamination with pre cleaning of used probes in the sink of patient testing rooms and if the patient room is not thoroughly clean before seeing the next schedule patient after cleaning of probes. The DON 1 stated this process was set up by SPD and she will need to follow up with the hospital SPD team. During an interview on 7/23/24 at 09:35 a.m. with the Manger of CVDS (MG 5), MG 5 stated after the observation yesterday on 7/22/24 at 3:35 p.m. her team had the chance to review the workflow. MG 5 stated that her team realized they were doing the pre cleaning of TEE probes that were used on patients in an area where they were also doing patient care. MG 5 stated CVDS team have stopped performing pre cleaning in the patient care area, in the ultrasound room 2, in between patient testing. MG 5 stated they now have dedicated room for pre cleaning of the probes. MG 5 stated the used probes should not be cleaned in the patient care area, in between patient testing, without cleaning the room in between as this had the potential for cross contamination and exposing patients to germs. MG 5 stated realized previous workflow had the “potential for infection control issue and the new process will eliminate that potential”. During an interview on 7/23/24 at 9:42 a.m. with the DIP, the DIP stated she was made aware of the process of pre cleaning of used TEE probes in between patient testing. The DIP stated the probes should not be cleaned in patient testing room in between patients or the room should have been terminally clean every time after the probe was pre cleaned in between patients. The DIP stated this new process is better and she was not aware of the previous process of pre cleaning until today. The DIP stated infection prevention team would have been concerned with the old process of cleaning TEE probes in between patient testing in ultrasound room two as it had the potential to cause harm to the patients by cross contamination. During an interview on 7/30/24 at 12:20 p.m. with the CNO, the CNO stated she was made aware of the previous process before 7/23/24 for TEE cleaning. The CNO stated the process of pre cleaning TEE probes in between patient testing, in patient care area was not an acceptable practice. The CNO stated probes have specific set of instructions for use and the hospital should be following the instructions. The CNO stated cleaning probes in patient rooms has the potential to expose clean patients to hospital acquired infections. 3. During a concurrent observation and interview on 7/24/24 at 10:51 a.m. with Manager of pharmacy -regulatory and compounding (MG 6) in the Cardiovascular Operating Room (CVOR) satellite pharmacy (decentralized operating unit which has similar function with the central inpatient pharmacy), observed [brand name] positive pressure recirculating compounding aseptic isolator (hood with positive airflow that provides a safe and clean environment for compounding (custom made) of hazardous, sterile drug preparation. Positive pressure is used to ensure there is no entry of the surrounding environment into the closed system) behind the red line. The floor directly below towards the front of [brand name] positive pressure recirculating compounding aseptic isolator and inside the red line had a hole with chunk of floor missing. The hole was approximately one inch deep and about two inches wide and appear to have dust particles in the hole. The MG 6 stated everything inside the red line supposed to be clean and only essential personal with proper personal protective equipment (PPE - equipment worn to minimize exposure to hazards) are allowed. The MG 6 stated the floor with holes/cracks inside the red line and below the compounding area is not acceptable. The MG 6 stated he was not sure what was collecting inside the hole. The MG 6 stated germs can harbor and “risk for cross contamination”. The MG 6 stated the floor need to be clean and disinfected to maintain sterility and holes and cracks would have the potential where germs can grow. During an interview on 7/24/24 at 12:30 p.m. with the director of quality (DQ), the DQ stated not acceptable to have any chips or cracks in the flooring in sterile compounding areas. The DQ stated “huge risk for cross contamination”. The DQ stated she had already escalated these concerns to senior leadership. During an interview on 7/26/24 at 11:38 a.m. with the Director of Pharmacy (DOP), the DOP stated cracked floors, holes in the flooring were not acceptable in compounding area and inside the redline. The DOP stated the pharmacy team already repaired the flooring. The DOP stated she was unable to comment on why it was missed by the staff that works in the CVOP satellite pharmacy as it was clearly visible and right in the front. The DOP stated cracks and holes in the floor can foster an environment for bacteria growth. The DOP stated it was important for pharmacy team to ensure clean and sterile compounding environment to keep the patients safe. During an interview on 7/30/24 at 12:22 p.m. with the CNO, the CNO stated the flooring in CVOR Satellite pharmacy needs to be intact. The flooring that was not intact was hard to clean and could be potential source for infections. During a review of facility’s policy and procedure (P&P) titled, “Compounding Sterile Preparation and Hazards Drugs,” with a revised date August 2020, the policy indicated, “ ...Cleaning schedule for Anteroom, Clean room and Segregated Compounding Areas ...Daily Cleaning ...Clean floors from furthest location in clean room out through ante-room (including pass-through floor -SPOROCIDAL AGENT ...Weekly Cleaning ...Floor (same as daily cleaning) ...” During a review of the AORN publication Outpatient Surgery article, “How to Maintain a Clean OR Environment,” dated 10/10/2007, the article indicated,”...To ensure a clean environment, evaluate the environment weekly or monthly for overall cleanliness as well as general condition...Are there cracks, nicks, or grooves on the floor? If so, repair them immediately to prevent bacteria from festering in the spaces...” During a review of the Health Facilities Management article titled, “The role of maintenance in infection prevention,” dated 8/16/19, the article indicated, “...Health care-associated infections (HAI) concerns to look for include: Damaged flooring in clinical areas. Damaged flooring does not provide a smooth, cleanable surface and can result in an infection prevention concern; Peeling paint or damaged wall surface. A wall surface that is not smooth is not cleanable...” 49538 1. Facility staff failed to identify a lifted floorboard in the pantry room on the Labor and Delivery unit. This failure had the potential for bacteria build up. Findings: 1. During a concurrent observation and interview on 7/22/24 at 3:08 p.m. with the Director of Women and Infant Services (DWIS) in the Labor and Delivery (L&D) pantry room, the floorboard was lifted from the floor. The DWIS stated, she was unsure if maintenance was aware of the lifted floorboard. The DWIS stated, it was an infection control issue and expected it to be fixed. During an interview on 7/25/24 at 3:10 p.m. with the Director of Infection Prevention (DIP), the DIP stated, the lifted floorboard in the L&D pantry room was not wipeable and cleanable. The DIP stated, the area needed to be smooth to be able to clean. The DIP stated, it was an infection risk because there were gaps where bacteria could settle into the cracks and cervices. The DIP stated, she expected the floorboard to be fixed and have a smooth surface to be cleanable. During a review of the facility’s policy and procedure (P&P) titled, “Plant Maintenance,” reviewed 3/17/23, the P&P indicated, “ ...PURPOSE: To develop a program that reviews components of life safety on a consistent basis ... POLICY: Plant Maintenance department will utilize the work order program to identify the following life safety equipment and ensure that these devices are checked on a regular basis to comply with recommendations for National Fire Protection Agency (NFPA) ... PROCEDURE ... Slab to slab penetrations, corridor separation quarterly ... Damaged walls repaired ...””

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 42321 Based on observations, interviews, and record reviews the hospital failed to follow policies designed meant to maintain high standards of medical practice and patient care in their surgical services department for six of six patients, Patient (Pt) 10, Pt 11, Pt 43, Pt 44, Pt 45 and Pt 46) when: 1. Surgical staff failed to read the complete expiration date on one of one titanium device prior to being transplanted in Patient (Pt) 11. The device was scanned once transplanted and it was found to be expired by 10 days. This failure placed Pt 11 at risk of device failure and possible infection due to transplanting an expired device. 2. Surgical staff failed to remove one of one expired suture from the operating room and the expired suture was used on Pt 10. Surgeon 2 was informed that the suture was expired and elected not to remove the expired suture. This failure place Pt 10 at risk of obtaining an infection at the site due to suture not holding. 3. Four of four patients’ (Pt 43, Pt 44, Pt 45, and Pt 46) Operating Room Reports (OP Reports - the surgery report that documents who is present in the OR during surgery and the time in and out for each staff member) dated 7/29/24 did not accurately reflect the name of the proctor for Certified Registered Nurse Anesthetist (CRNA) 2. According to the proctor report dated 7/29/24, CRNA 14 proctored CRNA 2. The OP reports for Pt 43, Pt 44, Pt 45, Pt 46 did not list CRNA 14 or in and out times and CRNA 2 was listed as the only anesthesia provider. These failures did not provide Pt 43, Pt 44, Pt 45 and Pt 46 accurate information as to the CRNA that provided anesthesia services for their procedures. 4. Surgical staff failed to notice one of one blue cauterization cart in OR 4 had paint chipped off in multiple areas and a brown reddish substance that looked like rust around the front left wheel. This failure had the potential to be a source of infection for any patients who had surgery with this cauterization cart in the room. 5. Surgical staff failed to identify one of one expired [brand name] certified airway exchange catheter (thin tube used in certain surgeries and medical procedures) on the Anesthesia cart in the Obstetrics (OB) OR. This failure had the potential for an expired product to be used on a patient. 6. Two of two staff members wore blue procedural area scrubs on the second floor of the hospital outside of a procedural area with blue booties over their shoes walking in the hallway and not in accordance with hospital policy and procedure for surgical attire. This failure had the potential to spread germs (microorganism which causes and spread disease) from the ORs to the hallways and from the hallways onto the OR floors. Findings: 1.During a review of Pt 11’s Face sheet (provides demographic information), dated 5/22/24, indicated Pt 11 was admitted on 1/23/24 at 5:49 a.m. as an inpatient for surgery, with a diagnosis of Arthrodesis status (a surgical procedure that fuses two bones in a joint) and a discharge date of 1/28/24. During a review of Pt 11’s Op (operative) Note dated 1/23/24, the Op Note indicated Pt 11 had the following procedure: Transforaminal Lumbar (L) Interbody Fusion L2-L3, L4-L5 (a surgical procedure that joins two or more vertebrae in the lower back using a bone graft spacer, screws, and rods), Revision Posterior Spinal Fusion L3-L4 (a surgical procedure that can be performed to improve pain and function), Posterior Spinal Fusion (a spinal surgery technique that can alleviate lower back pain and/or leg pain by removing a damaged spinal disc and fusing the pain-generating spinal segment), Instrumentation L2-L5 (a type of spinal fusion surgery that uses metal devices to stabilize the spine and help the fusion heal), and C-Arm (a medical imaging device that uses X-ray technology to visualize a patient’s anatomy during surgery). Pt 11’s Op Note indicated Implant “L4-L5: 8.5 x 28 x 10 mm (unit of measurement- millimeters) K2M Cascadia static titanium cage ... Addendum: At the end of the case after final implantations were placed, it was brought to my [Surgeon 1] attention that the implanted L4-5 titanium interbody cage had expired on 1/13/2024. Upon evaluation of the situation, I [Surgeon 1] determined that the risk of removing the interbody cage and replacing it outweighed the benefit ... The decision was made to keep the implant in place. The patient was informed of this postoperatively.” During an interview on 7/23/24, at 10:02 a.m., with the Director of Perioperative Services (DPS) stated the vendor brought in different sizes of the implant needed for Pt 11’s surgery, “however it is the responsibility of the [surgical] team to vet (to carefully examine something or someone to ensure it is acceptable or suitable) those implants. We have safeguards in place, but there are certain things that don’t scan and so our policy has always been that the circulator will validate; we’ll show it to the scrub tech, who will announce it, the device and full expiration date.” The DPS stated the vendor only stated the month and year of the implant and the surgical staff did the same, it was not noticed that the device was expired until it was scanned by the circulating nurse and by that time SUR 1 had already implanted it in Pt 11. During an interview on 7/23/24, at 10:10 a.m., with OR Manager (MG) 1, MG 1 stated the implant used on Pt 11 is a product the hospital does not stock and the vendors have to bring them in. MG 1 stated the representative from the vendor read off the month and year of the implant to be used on Pt 11. MG1 stated the circulating nurse did not check the date, but she opened the implant, and gave it to the scrub tech who passed it to the surgeon. MG 1 stated the visual check and reading out loud of the expiration date was missed between the circulating nurse and the scrub technician. MG 1 stated when the circulating nurse scanned the implant it came up as expired. MG 1 stated the surgical team was notified the device was expired and the surgeon felt it was in the best interest of Pt 11 to leave it in, since it was only 10 days passed expiration. MG 1 stated the facility follows the Association of periOperative Registered Nurses (AORN) guidelines. MG 1 stated the facility now scans the expiration date on the implants before they are opened. During an interview on 7/23/24, at 9:33 a.m., with Scrub technician (ST) 1, ST 1 stated she was the scrub technician in Pt 11’s case. ST 1 stated she remembers the circulating nurse reading off the date for the first implant which the surgeon did not use. ST 1 stated the surgeon asked for a larger size implant. ST 1 stated the vendor representative left the room and brought back a larger size and the full expiration date was not read out loud by the vendor or the circulating nurse, and then the opened implant was placed on the sterile tray for use. ST 1 stated she loaded the implant and gave it to the surgeon and the surgeon placed it in Pt 11. ST 1 stated the implant expiration date was not scanned until after it was inside Pt 11. ST 1 stated the surgeon did not want to remove the implant. During an interview on 7/23/24, at 1 p.m., with the Surgeon (SUR) 1, SUR 1 stated he does not check the expiration dates himself and depends on the staff at the hospital to do this. SUR 1 stated he made the decision to leave the titanium device implanted in Pt 11 when he learned that it was expired by two weeks because there is a risk of damaging the nerve if implants are removed and reinserted. SUR 1 stated Pt 11 has come in since surgery and there have been no signs of infection, he is recovering as expected. SUR 1 stated he informed Pt 11 of the expired implant that same day and the reason he decided to keep it in. SUR 1 stated since this happened, he now checks the date of expiration of the implants himself. During an interview on 7/23/24 at 10:44 a.m., with the Infection Preventionist (IP) 1, the IP 1 stated using an expired implant puts Pt 11 at risk for infection, when a product is expired, the concern is efficacy and sterility of the implant. During a review of the facility’s policy and procedure (P&P) titled, “Circulating Team Member Responsibilities”, dated 11/2023, indicated, “PURPOSE: To provide guidelines for safe, coordinated activities involved with patient care during surgical procedures by the circulating registered nurse (RN). Outcome: The RN provides a safe and sterile environment for the patient during surgical procedures... Policy: 1. It is the responsibility of the circulating nurse: A. To maintain standards to ensure aseptic technique at all times ... 2. During the surgical procedure... H. Charge for sterile processing department (SPD) supplies special equipment. Medications, implants, blades, and burs on appropriate chart sheet ... 3. Implants ... B. As implants are requested from the surgical scrub team. Implant information is. “Read-back” to the team prior to opening the package. 1) Verify correct implant and expiration date...” During a review of the facility’s P&P titled, “Scrub Team Member Responsibilities”, dated 11/2023, indicated, “PURPOSE: To provide guidelines for optimal patient care and safety in the surgical room. Outcome: The scrub team member will provide a sterile, safe environment during a surgical procedure... Policy: One. A scrub person will be assigned to operative procedures and will be responsible for providing assistance to physicians and their assistance. If present during operative procedures... procedure: One. Prior to surgical. Procedure: ... B. Assist in organizing special supplies and equipment for cases prior to scrubbing... K. Reconfirm patient procedure implant availability... F. Inform. The circulator of implants used information to include but not limited to: 1. Lot # 2. Amount used 3. Size 4. Site... J. Perform sponge, sharp and instrument counts as appropriate when surgeon begins closure of surgical case... 4. Implants A. Ensure all implants are available prior to bringing the patient into the operating suite. B. As implants are requested from the surgeon, that information is given to the circulating nurse. C. Prior to the circulating nurse opening the implant, confirm the implant is correct and the expiration date by visual reading the package. D. “Read-back” to the surgeon prior to opening the package...” 2. During a review of Pt 10’s Face sheet (provides demographic information), dated 2/8/24, indicated Pt 10 was admitted on 2/8/24 at 11:22 a.m. to the Outpatient Surgical Center (OSC) [name] with the following diagnosis of Collapsed vertebra in lumbar region. During a review of Pt 10’s Operative Report dated 2/8/24, the Operative Report indicated Pt 10 had a “permanent spinal cord stimulator implant” placed with no complications, performed by Surgeon (SUR) 2. During an interview on 7/23/24, at 9:45 a.m. with Circulating Registered Nurse (CRN) 1, CRN 1 stated she was the CRN for Pt 10’s surgery. CRN 1 stated SUR 2 had begun to suture Pt 10 as she voiced that the suture was expired. CRN 1 stated SUR 2 stated he was going to use the expired suture. CRN 1 stated the expectation is the expiration dates should be checked before the sutures come into the OR and the expiration dates are checked again by the scrub tech. During an interview on 7/23/24, at 9 a.m. with SUR 2, SUR 2 stated, “ ...The structure of the suture is minimal, it’s optional. There’s no clinical risk or benefit. I was given the suture, then they said it was expired. The clinical benefit was better to leave it in.” SUR 2 stated the purpose of the expiration is the theoretical degradation (gradual deterioration) of the suture [name of suture]. SUR 2 stated there has not been any testing to show [name of suture] the rate these sutures degrade. SUR 2 stated he did not tell Pt 10 about the expired suture while the patient was in the hospital but did tell Pt 10 at her first post op visit that the suture used was expired. SUR 2 stated Pt 10 is “doing splendidly”, and the wound has healed. During an interview on 7/23/24, at 10:18 a.m. with MG 1, MG 1 stated Association of periOperative Registered Nurses (AORN) states sutures should not be used beyond expiration date. During an interview on 7/23/24, at 10:12 a.m. with the DPS, the DPS stated on 2/8/24 she was made aware of the use of the expired suture used by SUR 2 on Pt 10. The DPS stated the OSC is an extension of [name of hospital] and had its own way of checking for expired supplies which multiple staff members were responsible for. The DPS stated the use of expired sutures did pose the risk of malfunction of the product or infection risk. The DPS stated they follow the hospital’s policy and follow AORN standards, which include to check for expiration dates. During an interview on 7/23/24, at 10:27 a.m. with the Manager of Infection Control and Prevention (MIP), the MIP stated she was made aware of the SUR 2 using the expired suture on Pt 10, shortly after the incident occurred. MIP stated expiration dates are important because the “Manufacturer will only guarantee sterility until that date” and if expired sutures are used it could be an infection risk to the patient. During a review of the facility’s policy and procedure (P&P) titled, “Outdating of Supplies in Procedural Area”, dated 10/2022, indicated, “PURPOSE: To ensure that all supplies managed by CD’s [central distribution] are current and have not expired. This policy applies only to those carts, cabinets, shelves, Omni cells and storage areas that are stocked and replenished by CD staff. Policy.: CD staff will be responsible only for verifying expiration dates in this flight carts, cabinet shelves, omni sells and storage areas that they replenish on a regular basis. Cards, cabinet shelves, Omni sells and storage areas containing supplies will be inspected for outdated products at least every 12 weeks. Any product, excluding consignment or graph tracker. That will be expiring in the following 90 days will be removed at the item’s location. CD staff must communicate with CD supervisor, inventory supervisor and this applying chain System Administrator and the surgery materials coordinator went items have been flagged or removed from a location. All outdated consignments. Graph tracker or serial number tracking consignment. Items are to be removed. Taken to central distribution and documented in the team’s log, the outdated item must be set aside for either the supply chain System Administrator or surgical. Materials coordinator to check. A list of mute items would be sent to specific areas. Management....” During a review of the facility’s policy and procedure (P&P) titled, “Circulating Team Member Responsibilities”, dated 11/2023, indicated, “PURPOSE: To provide guidelines for safe, coordinated activities involved with patient care during surgical procedures by the circulating registered nurse (RN). Outcome: The RN provides a safe and sterile environment for the patient during surgical procedures.... Policy: 1. It is the responsibility of the circulating nurse: A. To maintain standards to ensure aseptic technique at all times. B. To have all necessary supplies and equipment in readiness for the operative procedure. C. To ensure all instruments, sharps and sponge counts are correct.... Procedure: 1. Prior to surgical procedure: ... I. Assist scrub member with solutions, equipment, supplies, and surgical counts.... 2. During the surgical procedure... H. Charge for sterile processing department (SPD) supplies special equipment. Medications, implants, blades, and burs on appropriate chart sheet...” During a review of the facility’s P&P titled, “Scrub Team Member Responsibilities”, dated 11/2023, indicated, “PURPOSE: To provide guidelines for optimal patient care and safety in the surgical room. Outcome: The scrub team member will provide a sterile, safe environment during a surgical procedure.... Policy: 1. A scrub person will be assigned to operative procedures and will be responsible for providing assistance to physicians and their assistance. If present during operative procedures.... procedure: 1. Prior to surgical. Procedure: ... B. Assist in organizing special supplies and equipment for cases prior to scrubbing. C. Check equipment for proper functioning and ensure necessary equipment is available. D. Assist with opening of supplies... I. Set up surgical table in an organized way so equipment supplies can be used quickly and efficiently. J. Count sharps, sponges, and instruments with circulating nurse prior to procedure...” 3. During a concurrent interview and record review on 8/1/24, at 3:19 p.m., Pt 43, Pt 44, Pt 45, and Pt 46’s Face sheet, Case Information, Anesthesia Record and Proctoring Forms were reviewed with the Director of Perioperative Services (DPS). The DPS stated the circulating nurse should be documenting anyone in the Operating Room (OR) and their in and out times while in the OR. The DPS confirmed both the name of the Proctor and the in and out times for the Anesthesia providers for Pt 43, Pt 44, Pt 45, and Pt 46 were missing on the Case Information (includes the names and roles of all staff present during surgery) and on the Anesthesia Records dated 7/29/24. The DPS confirmed Certified Registered Nurse Anastasis (CRNA) 2 as the only Anesthesia provider listed in the Operating Room (OR) and on the Anesthesia Records dated 7/29/24 for all four patients and per the Proctor form dated 7/29/24 CRNA 2 was proctored by CRNA 14. During an interview on 8/2/24, at 12:30 p.m., with the Director of Anesthesia Services (AMD), the AMD stated when they are proctoring a provider the proctor does not usually put their name on the Anesthesia record. The AMD stated the circulating nurses should be documenting what providers are in the room along with the providers in and out times. The AMD stated the proctor’s name is usually documented on the Proctor form. The AMD stated he expects the proctor forms to be filled in completely. During a review of the facility’s P&P titled, “Surgical Services Policy & Procedure” titled, “Documentation, Intraoperative” dated last reviewed Nov. 2023, indicated, “PURPOSE: To provide an accurate account of the intraoperative phase of the surgical patient’s care. OUTCOME: Documentation is correctly and completely maintained during the intraoperative phase of the surgical patient’s care. POLICY: ... 4. All persons involved in the surgical procedure will be documented to include full name, title, company, or school name if applicable, and the times in and out of the OR ... 3. Case Attendees A. All surgical team members are entered in this area, including their name, role, and times they begin and end patient care. B. Document the full name of sales representatives, students, anyone who is not on the list of Case Staff, Include company or school name if applicable ...” 4.During a concurrent observation and interview on 7/25/24 at 11:15 a.m., while in Operating Room (OR) 4 with the OR Manager (MG) 1, a blue painted cauterization cart was seen with multiple areas of chipped paint and reddish-brown areas on the metal handle and the front left wheel of the cart had reddish brown substance that came off when touched. MG 1 stated that the substance on the wheel of the cart looked like rust. MG 1 stated this cart was an infection risk to the patients that have surgery. During an interview on 7/30/24, at 12:18 p.m. with the Chief Nursing Officer (CNO), the CNO stated equipment with rust should not be in the surgical suites, it should have been disposed of (referring to the blue cauterization cart). The CNO stated this is an infection risk to the patient. During a review of the facility’s policy and procedure (P&P) titled, “Circulating Team Member Responsibilities”, dated 11/2023, indicated, “PURPOSE: To provide guidelines for safe, coordinated activities involved with patient care during surgical procedures by the circulating registered nurse (RN). Outcome: The RN provides a safe and sterile environment for the patient during surgical procedures.... Policy: 1. It is the responsibility of the circulating nurse: A. To maintain standards to ensure aseptic technique at all times. B. To have all necessary supplies and equipment in readiness for the operative procedure. C. To ensure all instruments, sharps and sponge counts are correct.... Procedure: 1. Prior to surgical procedure: ... I. Assist scrub member with solutions, equipment, supplies, and surgical counts....” During a review of the facility’s P&P titled, “Scrub Team Member Responsibilities”, dated 11/2023, indicated, “PURPOSE: To provide guidelines for optimal patient care and safety in the surgical room. Outcome: The scrub team member will provide a sterile, safe environment during a surgical procedure.... Policy: 1. A scrub person will be assigned to operative procedures and will be responsible for providing assistance to physicians and their assistance. If present during operative procedures.... procedure: 1. Prior to surgical. Procedure: ... B. Assist in organizing special supplies and equipment for cases prior to scrubbing. C. Check equipment for proper functioning and ensure necessary equipment is available ...” 5. During a concurrent observation and interview on 7/22/24 at 4 p.m. with Manager (MG) 2 in the Labor and Delivery OR 1, the anesthesia cart had an expired [brand name] certified airway exchange catheter (thin tube used in certain surgeries and medical procedures). MG 2 stated, the catheter expired on 7/20/24 (2 days ago). MG 2 stated, it was the anesthesia technician’s responsibility to check the anesthesia cart for restocking and expired products. MG 2 stated, the department does not have access to the anesthesia cart and the anesthesia technicians had the key. MG 2 stated, the catheter should have been pulled from the anesthesia cart because it was expired. MG 2 stated, it was important to go based on the manufacturer’s expiration dates and the sterility of the product cannot be determined after the expiration date. MG 2 stated, the integrity of the catheter could be compromised, and it was a patient safety issue to use expired products. During an interview on 7/25/24 at 12:17 p.m. with Anesthesia Technician (AT) 1, AT 1 stated, anesthesia technicians were responsible to change supplies in the “difficult airway cart (anesthesia cart)” AT 1 stated, there was no schedule of when the difficult airway cart was checked. AT 1 stated, every three months during downtime an anesthesia technician would go to check the anesthesia carts. AT 1 stated, the product could be compromised if used past the expiration date. AT 1 stated, he expected products to be replaced before the expiration date. During an interview on 7/25/24 at 3:20 p.m. with the Director of Infection Prevention (DIP), the DIP stated, the sterility of a product is guaranteed before the expiration date and could pose an infection risk if used after the expiration date. The DIP stated, there should be multiple checks on expiration dates, but the end user was responsible to check for the expiration date before the product is used. 6. During a concurrent observation and interview on 7/22/24, at 11 a.m., with the Director of Perioperative Services (DPS), while on the second floor of the hospital outside of the elevators two of two staff members were seen in blue surgical attire and blue booties to cover their shoes walking down the hallway. The DPS stated the blue booties should not be worn outside of the procedural areas. The DPS stated there is a risk for cross contamination from the booties worn out of an OR into the hallways and from substances outside the ORs worn back into the ORs. The DPS stated it is an infection control risk. During an interview on 7/30/24, at 12:16 p.m. with the CNO, the CNO stated the expectation for where surgical attire should be worn (i.e. booties) is behind the red line and not on the other side of the red line (indicating they should stay in the procedural areas). The CNO stated the risk to patients and staff when this is not done is cross contamination. During a review of the facility’s P&P titled, “Attire in Restricted and Semi-Restricted Areas” dated 10/2023, indicated, “PURPOSE: To provide guidelines for surgical attire including jewelry, clothing, shoes, head covering, masks, jackets, and other accessories worn in the restricted and semi restricted areas of the surgical or invasive procedure setting. To promote work safety and a high level of cleanliness and hygiene within the perioperative environment. Outcome: Appropriate attire is worn in the restricted and semi restricted areas of [name of hospital] ... POLICY: 1. Employees, physicians, vendors, and observers, including students entering restricted and semi restricted areas will wear clean [name of hospital] provided surgical attire that has been laundered by a health care accredited laundering facility ... PROCEDURE: 1. Restricted Areas: ... B. Headwear: ... ii. Cover hair completely and replace headwear when contaminated ... D. Footwear: ... iii. Shoes worn outside the facility must be covered by shoe covers before entering the restricted semi restricted area. Shoe covers must be removed prior to leaving the restricted semi restricted area... H. Jewelry and accessories... 6. Remove surgical masks, head coverings and shoe covers when leaving the semi restricted areas...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 40644 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body . Based on observation, interview, record review, the facility failed to have an effective governing body legally responsible for the conduct of the hospital when: 1. The Governing Body (GB) did not ensure that the hospital had an active and effective quality assurance and performance improvement (QAPI) program that collected and analyzed data for improvement in patient care. (Cross-reference A 263, A 283) 2. The GB did not ensure that safe care was provided for a 36-year old woman who came to the hospital in alcohol withdrawal with critically low potassium, magnesium, and phosphorous levels. The patient was treated with supplemental potassium, magnesium, and phosphorous in the Emergency Department, but medication did not continue after the patient was admitted, and her blood was not tested timely to monitor if her blood levels were improving, her heart monitor was removed without an order or physician assessment, and the order for CIWA protocol was not followed. The patient had a cardiac arrest the next morning and was transferred to Intensive Care where she died. (Cross-reference A 398) Because of the serious actual harm to Patient 3 when nurses did not follow hospital policies and procedures and not to follow up on critical labs Immediate Jeopardy (IJ) situation was called for situation on 4/19/24 at 6:00 p.m., under Code of Federal A 0398 §482.42 in the presence of the President and Market Leader, the Chief Nursing Officer, The Chief Medical Officer, and the Director of Quality were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable plan of removal to address the IJ situation. Plan of removal was accepted on 4/22/24 at 3:30 p.m. Survey team’s observations and interviews validated the hospital implemented appropriate corrective actions and the IJ was removed on 4/22/24 at 5:00 p.m. in the presence of the Director Quality and the Manager of Quality and Accreditation. Following the IJ removal, the facility remained in substantial non-compliance. The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner for staff and patients.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 42321 Based on observation, interview, and record review, the hospital failed to protect and promote each patient’s rights when: 1.One of five sampled patients (Patient (Pt) 1) was admitted to the hospital for active labor and fetal heart monitoring was not reviewed during hand off from OB ED to L&D and Physician was not made aware of Category 2 tracing in OB ED. These failures resulted in Pt 1’s baby not being monitored appropriately and contributed to the baby’s death. (Refer to A0144, Pt 1) 2.One of three sampled patients (Pt 3) was admitted to the hospital and placed on CIWA protocol (Clinical Institute Withdrawal Assessment for Alcohol protocol - a specialized questionnaire designed to evaluate the intensity of alcohol withdrawal symptoms, aiding in guiding effective treatment strategies) and it was not followed nor was Pt 3 monitored appropriately. These failures resulted in Pt 3 not being assessed and possibly contributed to her death. (Refer to A0144, Pt 3) The cumulative effect of these systemic problems resulted in the hospital’s inability to provide care in a safe and effective manner in accordance with the statutory-mandated Condition of Participation for Patient Rights.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 40644 Based on interview and administrative record review, the hospital failed to implement and maintain an on-going, comprehensive, data-driven Quality Assurance and Performance Improvement (QAPI) program to improve both quality and safety when the hospital did not maintain a QAPI program which evaluated and monitored the safety of all of its services and the quality of patient care, with data collection and analysis, monitoring of implementation, and tracking performance to ensure that improvements are sustained. Review of recent past surveys for this facility indicated: 1.) During a survey dated 8/4/23, the facility was found to be in substantial non-compliance with 263 QAPI due to the facility failing to use data collected to identify opportunities for improvement. 2.) During a survey dated 10/16/23, the facility was found to be in substantial non-compliance with 263 QAPI due to the facility failing to analyze causes and implement preventive measures following an adverse event. 3.) During a revisit survey dated 1/25/24 (combined revisit for 1 and 2 above), the facility was found to be in substantial non-compliance with 263 QAPI when the facility failed to take actions aimed at performance improvement when corrective actions listed on a Plan of Correction (POC) for surveys 1 and 2 and were not implemented. 4.) The POC for the revisits has not yet been accepted. During this current survey, the facility was found to be in substantial non-compliance with 263 QAPI due to the facility failing to have an active and effective QAPI program. Previous Plans of Correction and survey findings have not prompted effective quality improvement projects to make a difference in overall compliance. During an interview on 4/25/2024 @ 3:00 p.m. with the Board of Directors, the CEO of the West Region (CEO) stated, “when I started about a year ago, we assessed the organization and saw there were gaps in quality as they had not filled key positions, and those who were in the positions did not have the expertise for the challenges we faced.” The CEO stated they have been “regulatory crisis” for the last year. The CEO stated, “we are not where we want to be.” The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality patient care in a safe environment.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to have an organized nursing service when: 1. One of three sampled patients (Pt 3) was not assessed for alcohol withdrawal symptoms and a low serum potassium (an electrolyte in the body that is important for the function of nerves and muscles -- normal value 3.6 to 5.2 mmol/L (millimoles per liter)) lab value and was not addressed with follow up and more analysis of the clinical condition of the patient as per hospital policy. 2. Three of five patients sampled (Patient (Pt) 1, Pt 23, and Pt 24) had epidurals (an injection in your back to stop you feeling pain in part of your body) placed and the hospital policy was not followed. Pt 1’s baby fetal heart tones (FHT) were not being monitored appropriately. (refer to A398) 3. Two of 10 sampled patients (Pt 26 and Pt 27) had orders for telemetry monitoring (continuous tracking of your heartbeat) and monitoring was not done appropriately per the hospital policy. (refer to A398) 4. One of one certified registered nurse anesthetist (CRNA 1) was observed placing an epidural in Pt 4 and not performing proper hand hygiene when CRNA 1 was seen removing dirty gloves and then placed on sterile gloves without performing hand hygiene in-between. (refer to A398) 5. One of three patients sampled (Pt 2) had a low serum glucose (sugar in the blood - normal value 70 to 100 mg/dL (milligrams per deciliter)) lab value and was not addressed with follow up and more analysis of the clinical condition of the patient. (refer to A398) 6. One of 10 patients sampled patients (Pt 7) were not assessed or re-assessed for pain before or after the administration of pain medication per hospital policy and procedure. (refer to A398) 7. One of 4 sampled patients (Pt 10) did not have vital signs documented every four hours as required by the clinical condition of the patient and per hospital policy and procedure. (refer to A398) 8. One of 10 sampled patients (Pt 25) had two consents for procedures/surgeries that were not signed and or witnessed appropriately per the hospital policy. (refer to A398) 9. The hospital failed to develop and keep current care plans for three of 10 patients in accordance with the policy “Patient Care Policy and Procedure - Documentation”. The primary care needs related to safety for Pts 6, 15 and 19 were not assessed and developed and not documented in the patients’ care plans. (refer to A396) Because of the serious actual harm to Patient 3 when nurses did not following hospital policies and procedures and did not to follow up on critical labs an Immediate Jeopardy (IJ) situation was called on 4/19/24 at 6:00 p.m., under Code of Federal A 0398 §482.42 in the presence of the President and Market Leader, the Chief Nursing Officer, The Chief Medical Officer, and the Director of Quality were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable plan of removal to address the IJ situation. Plan of removal was accepted on 4/22/24 at 3:30 p.m. Survey team’s observations and interviews validated the hospital implemented appropriate corrective actions and the IJ was removed on 4/22/24 at 5:00 p.m. in the presence of the Director Quality and the Manager of Quality and Accreditation. Following the IJ removal, the facility remained in substantial non-compliance. The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality health care by the nursing staff.”

“ANESTHESIA SERVICES CFR(s): 482.52 If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital. This Condition is not met as evidenced by: 44907 Based on observation, interview and record review, the hospital failed to provide anesthesia services in a well-organized manner when: 1. The hospital failed to follow Medical Staff Bylaws, Rules and Regulations and California state law and ensure anesthesia services were appropriate to a Certified Registered Nurse Anesthetist’s (CRNAs- a nurse trained to provide anesthesia (specialized care before for surgery, pain management, critical care and emergencies) as “independent practitioners” and the same as anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic and therapeutic authority). (Refer A1001) 2. Anesthesiologist (physician who provides specialized care before, during and after surgery, procedures to decrease pain) did not complete the pre-anesthesia procedure for Pt 1’s and her fetus prior to initiating a labor epidural (a type of regional anesthesia where a doctor places a catheter tube in the patient’s back and infuses medication to decrease labor pain). (Refer to A 1003) 3. Anesthesiologists (physician who provides specialized care before, during and after surgery, procedures to decrease pain) failed to provide ongoing evaluations of a labor epidural with continuous medication infusions and delegated anesthesia tasks to nurses who were not qualified to administer anesthesia. (Refer to A1004) 4. Anesthesiologist (physician who provides specialized care before, during and after surgery, procedures to decrease pain), failed to provide a post-operative procedure evaluation who received regional anesthesia and delegated anesthesia tasks to nurses who were not qualified to administer anesthesia. (Refer to A1005) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 40644 Based on observation, interview, and record review the hospital failed to provide care in a safe setting for two of 34 patients sampled (Pt 1 and Pt 3) when: 1.Pt 1 was admitted to the hospital for active labor and fetal heart monitoring was not reviewed during hand off from OB ED (Obstetrics Emergency Department) to L&D (Labor and Delivery) and Physician was not made aware of Category 2 tracing in OB ED. These failures resulted in Pt 1’s baby not being monitored appropriately and contributed to the baby’s death. 2.Pt 3 was admitted to the hospital and placed on CIWA protocol (Clinical Institute Withdrawal Assessment for Alcohol protocol - a specialized questionnaire designed to evaluate the intensity of alcohol withdrawal symptoms, aiding in guiding effective treatment strategies), and it was not followed nor was he monitored appropriately. These failures resulted in Pt 3 not being monitored appropriately and possibly contributed to his death. Findings: 1.During an interview on 3/28/24 at 3:42 p.m. with Patient (Pt) 1, Pt 1 stated she did not have any complications during her pregnancy. Pt 1 stated her last appointment with her obstetrician was on 3/12/24, which was her due date. Pt 1 stated she was dilated to 3 centimeters (meaning her cervix was dilated; cm- indicates a unit of measurement where 10 cm is fully dilated and ready to give birth). Pt 1 stated she had a non-stress test (NST) scheduled for 3/15/24 but ended up going into labor on 3/14/24. Pt 1 stated she went to the hospital when the contractions got stronger and arrived at approximately 4:30 p.m. Pt 1 stated she went to the fourth floor OB triage (same as OB ED) where she was registered and had her vital signs taken. Pt 1 stated the nurse tried to get the baby’s heartbeat but was not able to. Pt 1 stated she was taken to the OB triage room to a bed where they hooked her up to the fetal monitor and she could hear the baby’s heartbeat. Pt 1 stated the nurse told her the heart rate was 133 (beats per minute [bpm]). Pt 1 stated she stayed in the triage bed while she waited for a bed in labor and delivery. Pt 1 stated the fetal monitor was disconnected before she was transported to the sixth floor labor and delivery unit. Pt 1 stated when she got to the labor room, she requested an epidural but was told the anesthesiologist was with another patient, so Pt 1 went to the restroom and then walked back to bed. Pt 1 stated the nurse had her sit on the edge of the bed to wait for the anesthesiologist and the nurse did not put the fetal monitor on. Pt 1 stated the nurse could not put the monitor on her because her back was arched, so the nurse was in front of her holding the monitor on her abdomen. Pt 1 said she signed the consent, the anesthesiologist put in the epidural and then they laid her back down on the bed and put the fetal monitor on her but could not find the heartbeat. Pt 1 said they brought in a doppler and still could not find it. Pt 1 stated the doctor (MD 2) came in and used an ultrasound machine and said there was no heartbeat and no movement. Pt 1 stated a lady put her hands on Pt 1’s stomach and “shook it to get him [the baby] moving,” and another nurse asked about going to the operating room for a c-section. Pt 1 stated the doctor (MD 2) “decided no c-section, let’s let it come naturally.” Pt 1 stated her baby had a heartbeat when she was in triage and questioned why they couldn’t have resuscitated him. Pt 1 stated “they wrote the time of death at 6 p.m. and I asked if they were 100% positive. They said yes, he was gone, and they were going to confirm with another ultrasound. I’m thinking why wait so many hours after to do an ultrasound, why not do a c-section?” During a review of Pt 1’s face sheet, dated 4/19/23, Pt 1’s face sheet indicated Pt 1 was a 36-year-old female who was admitted on 3/14/24 for the following diagnosis of Normal labor. During a concurrent interview and record review on 4/9/24 at 3:20 p.m. with Obstetric Emergency Department (OB ED) Registered Nurse (RN 5), Pt 1’s medical record was reviewed. The record indicated Pt 1 was 40 weeks and two days pregnant with her fourth baby. Review of the “Labor and Delivery [L&D] Timeline” indicated Pt 1 came to the OB ED on 3/14/24 at 4:38 p.m. with a chief complaint of contractions which started at 3 a.m. that morning. Pt 1 was moved from the waiting room to a bed in the OB ED at 4:45 p.m. The L&D Timeline indicated at 5 p.m., an external fetal monitor was in place and the fetal heart rate (FHR) was 140 beats per minute (bpm). There was no assessment of the unborn baby’s FHR variability, presence, or absence of accelerations and/or decelerations, or characteristics of uterine contractions. Pt 1’s pain level was 7/10 (meaning on a scale of 1 to 10, pain level was 7, or moderate to severe pain). At 5:02 p.m., a cervical exam indicated Pt 1 was dilated to 6 cm, intact membranes, 70% effaced (effacement- thinning and shortening of the cervix), and the presenting part was at a minus 2 station (The location of the baby’s presenting part [head] is in relationship to the ischial spines of the pelvis). At 5:05 p.m., admission orders were entered into the electronic health record (EHR) by RN 4 as “Telephone orders with readback [when the physician gives orders over the phone to the RN, and the RN reads those orders back to the physician to confirm accuracy].” The orders included intravenous (IV) fluid, lab tests, medications for pain and an order for an epidural. At 6:54 p.m., RN 4 documented a provider notification note for 5:09 p.m. which indicated “Provider in [Operating Room] OR, RN to enter orders.” RN 5 stated there is no documentation in the record indicating RN 4 spoke with the obstetrician (MD 2) or attempted to contact MD 2. RN 5 stated if an RN needed to communicate with a physician who was in the OR, a call could be made into the OR to directly speak with the physician, or to a nurse in the OR. RN 4’s note indicated Pt 1 was having contractions every 1-5 minutes lasting 60-90 seconds, the FHR was 140 bpm, with absent accelerations and minimal variability. RN 4’s note also indicated Pt 1 requested an epidural and that this request was communicated by RN 4 to the Practice Coordinator (PC 2) in L&D. At 5:42 p.m., RN 4’s note indicated the FHR was 145 bpm, minimal variability, absent accelerations, and variable decelerations. Fetal monitoring was discontinued at 5:42 p.m. There was no indication that RN 4 attempted to notify MD 2 of the minimal FHR variability or absent accelerations for the 42 minutes of fetal monitoring, or the variable deceleration. During a concurrent interview and record review on 4/9/24 at 3:55 p.m. with OB ED RN (RN 5), Pt 1’s medical record was reviewed. Review of the L&D timeline indicated Pt 1 was transferred from the OB ED on the fourth floor to labor and delivery on the sixth floor at 6:04 p.m., with report given by RN 4 to L&D RN (RN 2). RN 5 stated there is nothing else documented from 5:42 p.m. until 6:09 p.m. when vital signs were obtained, and no documentation of fetal status after 5:42 p.m. The record indicated a consent form for anesthesia was signed by Pt 1 at 6:10 p.m. and review of the anesthesiologist (MD 4) notes indicated at 6:23 p.m. an epidural catheter was placed and at 6:25 p.m. the epidural medication was started. The fetal monitor strips beginning at 6:04 p.m. did not reflect a baseline fetal heart rate. RN 5 stated there was no documentation of an assessment of the FHR after 5:42 p.m., and no assessment by the obstetrician (MD 2) prior to placement of the epidural. Review of RN 10’s notes indicated at 6:25 p.m. RN 10 repositioned Pt 1 following epidural placement and attempted unsuccessfully to obtain a FHR. The OB ED on-call physician (MD 2) was notified and was at Pt 1’s bedside at 6:36 p.m. MD 2 performed a bedside ultrasound and confirmed there was no FHR. Review of MD 2’s OB history and Physical dated 3/14/24 at 6:59 p.m. indicated, “...I was called to the bedside in my role as the OB ED Laborist to assess an urgent issue, the inability to find fetal heart tones. This was the first time I was notified that the patient was admitted for active labor...” A review of MD 2’s OB Vaginal Delivery Note dated 3/15/24 at 12:01 a.m., indicated Pt 1 had delivered a stillborn male infant at 11:33 p.m. on 3/14/24 with a “There was a large 6 inch clot noted in the cord at the fetal insertion...Intact placenta delivered on 3/14/24 at 11 :36 p.m. Membranes were meconium stained...” During a review of the fetal monitor strip dated 3/14/24 beginning at 5 p.m. and ending at 5:42 p.m., the monitor strip indicated a baseline fetal heart rate of 140-145 bpm, minimal FHR variability, and no FHR accelerations. At 5:36 p.m., the monitor strip indicated a variable deceleration. There were also several instances where the heart rate did not record, at 5:05 p.m. for less than one minute, at 5:09 p.m. for approximately two minutes, at 5:23 p.m. for less than one minute and at 5:29 p.m. for approximately two minutes. The monitor strip stops at 5:42 p.m. and 50 seconds and does not resume until 6:04 p.m. A review of the fetal monitor strip dated 3/14/24 beginning at 6:04 p.m. and ending at approximately 6:16 p.m., indicated between 6:04 p.m. and 6:08 p.m. a baseline FHR could not be determined, and from 6:08 p.m. until 6:16 p.m. there is sporadic recording of a heart rate of 100-110 bpm and there are no corresponding nurses notes to provide an explanation for what is reflected on the monitor strip, and no indication in the record that the maternal pulse was assessed at the same time as the fetal heart rate in order to ensure the fetal heart beat was correctly identified. During a concurrent interview and record review on 4/11/24, at 3 p.m., with Registered Nurse (RN) 4, Pt 1’s electronic health records (EHR) for her admission on 3/14/24 was reviewed. RN 4 stated she was the primary OB ED nurse for Pt 1 on 3/14/24; Pt 1 arrived in the OB ED and presented in active labor, dilated to 6 cm, and having painful contractions. RN 4 stated she never contacted the in-house OB ED physician who was covering for Pt 1’s obstetrician. RN 4 stated she knew the in- house physician was in the OR (operating room) in a c-section and did not want to disturb her, so she put in the “telephone orders with readback” knowing that this was not true. RN 4 stated she did not get admitting orders to include the epidural orders from the doctor and did not read them back to anyone and she knew this was wrong. RN 4 stated she knew she could call into the OR and either speak with the doctor or the nurse and relay that this patient was here, and she needed orders, but she just did not do that. RN 4 stated she moved Pt 1 up to Labor and Delivery (L&D) and recalls giving report, but it did not include the reviewing the fetal heart rate monitor strip which reflected a category 2 tracing (category 1 is normal baby heart rate 110-160, moving; category 2 minimal movement of baby’s heart rate still 110-160 but concerning- needs to be addressed). RN 4 stated, “it was inappropriate” of her to have not reviewed the FHR strip with the nurse receiving Pt 1. During an interview on 4/11/24 at 4:25 p.m. with RN 10, RN 10 stated she was the L&D nurse who received Pt 1 from OB ED on 3/14/24. RN 10 stated PC 2 told her Pt 1 was going to have an epidural. RN 10 stated she met RN 4 and Pt 1 at the elevator and received report from RN 4. RN 10 stated she was provided a brief report about Pt 1 and was told Pt 1 wanted an epidural. RN 10 stated she did not receive report regarding the status of the baby including the FHR tracing. RN 10 stated she would have expected to be informed if there were any concerns about the baby. RN 10 stated she assumed RN 4 notified the physician and obtained orders from the physician. RN 10 stated the anesthesiologist was getting set up when Pt 1 arrived in L&D. Pt 1 went to the bathroom and came back and sat on the side of the bed for the epidural procedure. RN 10 stated she was positioned at bedside down in front of Pt 1 and held the ultrasound from the fetal monitor up against Pt 1’s abdomen in an attempt to obtain the fetal heart rate while the epidural was being placed. RN 10 stated she did not look at the fetal monitor during the epidural while she held the ultrasound on pt 1’s abdomen and thought at the time she was hearing the fetal heartbeat. RN 10 stated after the epidural was in, she repositioned Pt 1 lying down and then attempted to obtain the FHR but did not detect a heartbeat. RN 10 stated she did Leopold’s maneuvers (abdominal palpation used to determine fetal presentation) but did not feel any fetal movement. RN 10 stated she called for assistance and MD 2 was called to the bedside. RN 10 stated MD 2 performed an ultrasound and did not detect a heartbeat. During an interview on 4/16/24 at 1:40 p.m. with PC 2, PC 2 stated she was the PC on the day shift in L&D on 3/14/24. PC 2 stated she was notified that Pt 1 was in the OB ED, was in active labor and needed a bed. PC 2 stated she was also contacted by RN 4 to notify her that Pt 1 had requested an epidural, so PC 2 could let the anesthesiologist in L&D know for planning purposes. PC 2 stated that was the extent of the information she was given about Pt 1 and did not know the fetal monitor strip in OB ED indicated a Category II tracing. PC 2 stated she was called after RN 10 could not find a FHR after the epidural was placed. PC 2 stated she did not find out until after the dayshift ended at 7:30 p.m. that RN 4 did not call MD 2 to notify her of Pt 1’s arrival, contractions, cervical exam, and results of fetal monitoring, and did not obtain telephone orders from MD 2 for admission and an epidural. PC 2 stated if she was asked for help contacting a physician who was in the OR, she would have done that. PC 2 stated she expected the RN in OB ED to provide report to the L&D RN regarding the well-being of the patient and the baby including a review of the fetal monitor strip, and to have notified the physician and obtained orders for admission and labor prior to transferring the patient to L&D. PC 2 stated fetal well-being should be determined prior to a labor epidural being placed. During an interview on 4/16/24, at 3:20 p.m., with the Interim OB Director (OBD), the OBD stated she expects that a RN to RN report at transfer includes a review of the fetal monitor strips. OBD stated a nurse should never indicate an order was obtained from a physician by telephone unless it was. OBED stated of course MD2 should have been notified of Pt 1, including the results of the fetal monitoring while Pt 1 was in the OB ED. The OBD stated fetal well-being should be established prior to the patient receiving an epidural. During an interview on 4/16/24 at 10:35 a.m. with the Chief Medical Officer (CMO), the CMO stated in a hospital with in-house obstetrician coverage twenty-four hours a day and the capability for fetal monitoring twenty-four hours a day, an intrapartum fetal death should not occur. During a review of the State of California Certificate of Fetal Death issued on 4/8/24, the certificate indicated, “...THIS FETUS- DATE OF EVENT [Fetal Death]: 3/14/2024 HOUR: 1800 [6 p.m.] ...” The Certificate of Fetal Death was signed by MD 2 on 4/2/24. During a review of the [Name of Hospital] website accessed 4/12/24 at 6:46 p.m., the website indicated, “As part of our vision to elevate the level of care and service we provide to expectant moms, [Name of hospital] is proud to provide the Central Valley area’s only OB Emergency Department (OBED) that is staffed 24/7, 365 days a year, with Board Certified OB/GYN hospitalists. If you are greater than 20 weeks and have an urgent or emergent pregnancy-related need, take comfort in knowing that you will be seen by one of our OB/GYN hospitalists or your personal OB/GYN - regardless of time, complications, or circumstances.” During a review of the P&P titled, “Care of the Obstetrical Emergency Department [OB ED] Patient,” dated 6/20, the P&P indicated, “...Patients that are 20 weeks gestation or greater that present to the OB ED with obstetrical complaints other than scheduled Inductions/Cesarean sections, may be assessed and observed for no more than four (4) hours in the OB ED...A qualified Obstetrical triage nurse will briefly and accurately evaluate all patients based upon urgency of complaints or time of arrival if equal urgency, including but not limited to chief complaint and clinical status, using the Maternal Fetal Triage Index (MFTI a 5-level system to facilitate the care of pregnant women seeking care in an obstetrical triage unit [priority 1 being the highest acuity and priority 5 being the lowest acuity])...After triage assessment, patients who do not require immediate care shall be assigned to an exam room as soon as possible...Continuous fetal monitoring will be initiated as applicable for pregnancy gestations 24 weeks or greater, and a Non-Stress Test [NST] conducted to evaluate fetal heart rate, variability, presence of periodic and/or episodic patterns, fetal movement and presence of contractions...A complete nursing assessment shall include, but is not limited to maternal physical status, fetal status, labor status, psychosocial needs and patient interview...The primary Physician/On-call Physician/Hospitalist shall be notified after the initial assessment is complete...” During a review of the P&P titled, Scope of Services for the Obstetrical Emergency Department,” dated 4/20, the P&P indicated, “...The OB ED is open for service to Obstetrical patients, physicians and staff twenty-four (24) hours a day, seven (7) days a week. Then OB ED delivers care to pregnant patients of all ages, 20 weeks gestation or greater, who are experiencing uncomplicated emergency and/or remedial problems associated with pregnancy...The [Name of Hospital] OB ED shall fulfill the following responsibilities: a. Assessment, evaluation, management, and treatment, that is appropriate and timely to patients with obstetric conditions. b. Definitive care for those patients not requiring greater in-depth expertise or follow-up care. c. Provision of care that begins in the prehospital setting (provided by EMS), continues in the OB ED, and concludes with responsibility for the patient transferred to the Labor and Delivery [L&D] Unit, another unit, to another physician, or the patient is discharged...The Obstetrical Unit of ED will be covered by Board Certified OB/GYNs to include private physicians and OB Hospitalist program. The Hospitalist group will remain in hospital 24/7 to provide emergency coverage and provide medical care to the uninsured, no established prenatal care patients...Patients are triaged upon arrival, they are seen on the basis of acuity, otherwise they are treated on a first-come, first-served basis...All patients entering the OB ED shall be assessed by an RN...Patients will be classified according to the Maternal Fetal Triage Index...” During a review of the policy and procedure (P&P) titled, Epidural Anesthesia For Labor Patients, Patient Controlled,” dated 12/21, the P&P indicated,”...PURPOSE: To provide guidelines to nursing staff in assisting the anesthesiologist with epidurals for Labor and Delivery, considering care for mother and unborn fetus. POLICY: Continuous epidural anesthesia is administered by a qualified provider as described by the American Society of Anesthesiologists...Candidates for epidural anesthesia will be agreed upon by the anesthesiologist and the obstetrician. PROCEDURE: Pre-Procedure by RN: Apply Fetal Monitor and assess the FHR. Notify the obstetrician and obtain an order of patient request for epidural anesthesia. Notify anesthesiologist assigned to labor and delivery...Assess the fetal heart rate as continuous as possible during the procedure...Monitor fetal heart rate and contractions continuously during epidural infusion...” During a review of the policy and procedure (P&P) titled, “Fetal Heart Rate And Uterine Surveillance,” dated 8/23, the P&P indicated, “... Procedure for External EFM Ultrasound Application- Validate the fetal heart rate by auscultation before placing the transducer. Assess and confirm FHR baseline rate, baseline variability, and FHR pattern characteristics [presence or absence of accelerations and/or decelerations], and interventions as appropriate using the NICHD definitions. Differentiate fetal heart tracing with maternal heart rate upon admission and as clinically indicated. This can be done by checking the mother’s pulse, or briefly with the pulse oximeter.... Include in RN and OB Provider shift handoff communications: Admission FHR and uterine pattern, Current FHR and uterine pattern, and Significant events and interventions in labor ...All patients presenting to Labor and Delivery units at viability should undergo an initial period of electronic fetal monitoring for a minimum of 20 minutes or until fetal well-being is assured after the MFTI (maternal fetal triage index) is assigned. Monitoring for longer periods may be continued depending on the clinical circumstances... Documentation regarding assessment of FHR pattern and uterine activity: Use the full description of the FHR tracing per NICHD definitions to include FHR baseline rate, baseline variability, and FHR pattern characteristics (presence or absence of accelerations and/or type of decelerations), and interventions as appropriate. Document the actions taken to maintain a continuous FHR tracing and/or uterine activity tracing ... Manage the FHR patterns based upon the interpretation of the tracing ... Management algorithm for intrapartum fetal heart rate [FHR] tracing. Category II-evaluation and surveillance. Absent FHR accelerations and Absent/Minimal FHR variability- Initiate intrauterine resuscitation as appropriate for Category II patterns and document interventions...Documentation regarding Indeterminate (Category II) / Abnormal (Category III) FHR Patterns includes duration of the indeterminate/abnormal FHR pattern, clinical context (e.g. tachysystole, maternal hypotension, maternal temperature, bleeding, medications, etc.), specific intrauterine resuscitation measures implemented and the maternal- fetal response, and notification of the OB Provider and the content of the conversation. Examples of Category II FHR tracings include any of the following: ...Minimal baseline variability [Minimal variability- Amplitude range is greater than undetectable and less than or equal to 5 bpm] ...” During a review of the policy and procedure (P&P) titled, “Orders Management,” dated 1/2020, the P&P indicated, “...Telephone /Verbal Orders are accepted in limited situations: A. Communication of orders by this method is limited to urgent situations where immediate written or electronic communication is not feasible. B. The appropriate communication type (Telephone or Verbal) is selected. C. The entire order is entered and then read back and confirmed to the ordering Licensed Independent Practitioner [LIP]...” During a review of the professional reference titled, “American College of Obstetricians and Gynecologists Committee Opinion Number 667, Hospital-based Triage of Obstetric Patients,” dated 7/2016 (reaffirmed 2020), the reference indicated, “...An individual or individuals determined qualified as designated by hospital policy must perform an appropriate medical screening examination to determine whether the patient has an emergency medical condition. This determination should take into account the health of the woman and the fetus...” During a review of the professional reference titled, “American Society of Anesthesiologists Statement on Neuraxial Analgesia or Anesthesia in Obstetrics,” dated 10/13/21, the reference indicated, “...Neuraxial analgesia or anesthesia should not be administered until: 1) the patient has been examined by a qualified individual; and 2) a physician with obstetrical privileges to perform operative vaginal or cesarean delivery, who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia, is readily available to supervise the labor and manage any obstetric complications that may arise. Under circumstances defined by department protocol, qualified personnel may perform the initial pelvic examination. The physician responsible for the patient’s obstetrical care should be informed of her status so that a decision can be made regarding present risk and further management. Neuraxial analgesia for labor and/or vaginal delivery requires that the parturient’ s vital signs and the fetal heart rate be monitored and documented by a qualified individual...” During a review of the professional reference titled, “Practice Guidelines for Obstetric Anesthesia An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology,” dated 2/2016, the reference indicated, “... Conduct a focused history and physical examination before providing anesthesia care. This should include, but is not limited to, a maternal health and anesthetic history, a relevant obstetric history, a baseline blood pressure measurement, and an airway, heart, and lung examination, consistent with the ASA “Practice Advisory for Preanesthetic Evaluation.” A communication system should be in place to encourage early and ongoing contact between obstetric providers, anesthesiologists, and other members of the multidisciplinary team. Fetal heart rate patterns should be monitored by a qualified individual before and after administration of neuraxial analgesia for labor...” During a review of the professional reference titled, “ AHRQ Publication No. 17-0003-18-EF, AHRQ Safety Program for Perinatal Care- Monitoring for Perinatal Safety: Electronic Fetal Monitoring [EFM],” dated 5/17, the reference indicated, “...Key Safety Elements that support the safe use of EFM:...Teamwork Training-Components of Teamwork Training... Situational awareness during use of EFM refers to all staff caring for the patient knowing what the patient’s plan is through briefings and team management, being aware of what is going on and what is likely to happen next, and what resources are available if needed. In the context of EFM, situational awareness is particularly relevant for Category II tracings, where continued surveillance is often required before a definitive course of action can be determined, and staff need to know what resources are available to them should the patient’s status suddenly change...Use of transition communication techniques to ensure a shared mental model of plan of care and perceived risks between shifts or between units...” During a review of the professional reference titled, “ National Library of Medicine StatPearls: Fetal Monitoring,” dated 1/24, the reference indicated, “...During the first two stages of labor, fetal circulation is subject to compression as the fetus changes position and as uterine contractions occur, and this has the potential to lead to hypoxia and/or acidosis, which may induce fetal distress predisposing to poor outcomes. In monitoring the fetal status, clinicians should pay attention to the baseline fetal heart rate (FHR), variability, accelerations, and decelerations. Category II patterns may involve tachycardia, bradycardia, reduced or marked variability, and/or occasional variable or late decelerations. These patterns may indicate a wide range of fetal and maternal disorders and prompt further investigation into the underlying cause and may necessitate maternal or fetal resuscitation. Category II patterns may resolve spontaneously to become category I, at which point no intervention is necessarily warranted. However, closer observation is needed as the pattern may deteriorate to category III ...” 2. During a concurrent interview and record review on 4/19/24 at 10:00 a.m. with Manager (Mgr) 4, the Electronic Medical Record (EMR) for Patient (Pt) 3 was reviewed. The facility document titled, “ED (Emergency Department) Provider Notes” dated 4/13/2024 at 5:03 a.m. by MD 12 indicated, “History of present illness: 36-year-old female with history of arthritis, anxiety, and depression BIBA (brought in by ambulance) with a complaint of AMS (altered mental status - not thinking or acting as usual.) ... history of heavy alcohol abuse but no known medical problems EMS (Emergency Medical Service) ... noticed numerous empty vodka and beer containers with patient appearing altered. Upon arrival I was able to appreciate patient with [symptoms of] withdrawing from alcohol ...initiate CIWA protocol (CIWA, Clinical Institute Withdrawal Assessment for Alcohol is an assessment tool used by doctors and nurses designed to evaluate the intensity of alcohol withdrawal symptoms and gives guidance on medication management based on the CIWA score.) During a review of MD 12’s orders dated 4/13/24 at 5:46 a.m., an order for a CIWA protocol was initiated with an expiration date of 4/16/24. During a concurrent interview and record review on 4/19/24 at 11:00 a.m. with the Director of Emergency Department (Dir 2), Dir 2 reviewed the laboratory (lab) blood test orders and stated the first blood draw on 4/13/24 at 6:03 a.m. for electrolytes (necessary minerals in blood and other body fluids that carry an electric charge) Pt 3’s potassium (K+ - one of the electrolytes) and results were called to MD 12 on 4/13/24 at 6:51 a.m. Pt. 3’s K+ level was reported as a dangerously low level of 2.0 (normal range is 3.5-6.2.) On 4/13/24 at 7:07 a.m., MD 12 ordered intravenous (IV) K+ to infuse at 10 mEq (milliequivalents - a unit of measure) in 100 mL fluid per hour over the next 8 hours. MD 12 also ordered 40 mEq of K+ to be given PO (by mouth) at the same time. At 3:04 p.m., Pt 3’s blood was redrawn and her K+ was 2.2, a very slight increase. At 3:57 p.m., MD 8 ordered, “Potassium chloride 40 mEq PO x 2 doses” and the first dose was given at 3:58 p.m. The EMR indicated, Pt 3 was then transferred from the ED to 2 West, an acute medical unit and was placed on a telemetry monitor (wires attached to the chest to monitor heart rate and rhythm.) Pt 3 arrived on 2 West at 5:51 p.m. and received her second dose of potassium chloride 40 mEq PO at 6:05 p.m., completing the order from the ED. Dir 2 was unable to find an order to recheck Pt 3’s K+ level until 4:03 a.m. the next morning on 4/14/24, and there was no order for additional K+ medication. During a concurrent interview and record review on 4/19/24 at 10:32 a.m. with the Manager of 2 West (Mgr 2) and Mgr 4, Mgr 2 reviewed the EMR for Pt 3 and stated no K+ was given after 6:05 p.m. on 4/13/24 and no repeat lab draw was done until 4:13 am on 4/14/24. The CIWA order set (preapproved physician orders for patient’s experiencing alcohol withdrawal) was reviewed. The document titled, “Initiate CIWA-Ar assessment (Order 1021465339)” indicated, “Comments: Initiate CIWA-AR Assessment 1. If score is LESS than 10 (mild to no withdrawal symptoms); reassess every 2 hours x 2, then every 4 hours ...” Mgr 2 stated the nursing documentation indicated. Pt 3 had a CIWA score of 6 at 5:39 p.m., and a score of 8 at 7:12 p.m. There is no documentation indicating the nurses continued to assess Pt 3 and no further CIWA scores are in the chart. Mgr 2 stated with the score increasing from 6 at 5:39 p.m. to 8 at 7:12 p.m., the patient should have been reassessed two hours later at about 9:12 p.m. to ensure that the score wasn’t continuing to increase. Mgr 2 stated there was no assessment at 9:12 p.m., and no further assessments throughout night. The nurses note dated 4/14/24 at 12:20 a.m. by RN 2 was reviewed. The nurses note indicated, “ ...End of shift summary: maintained on CIWA monitoring, refused remote telemetry monitoring MD aware, continue with plan of care, hourly rounding ...” Mgr 2 stated the night shift did not end until 07:30 a.m. on 4/14/24. The text message from Registered Nurse (RN) 2 sent to MD 9 on 4/13/24 at 10:07 p.m. was reviewed. The text message indicated, patient is “refusing to keep her remote telemetry monitor on, we had been replacing it back several times, but she keeps on removing it claiming that the leads make her itchy. She had been asking if she can go home tonight but we told her that it will be against medical advice. She said she’ll think about it and does not want the monitor on.” MD 9 responded with “okay that’s fine.” RN 2 checked Pt 3’s vital signs at midnight, and Pt 3’s heart rate was 107 beats per minute, a fast heart rate. Pt 3’s heart rate at 2:30 a.m. was 114 beats per minute. Pt 3’s MD was not contacted to inform regarding the high heart rate. Mgr 2 stated the CIWA assessments should have continued through the night, and pulling at the monitor and ahigh heart rate are signs of agitation for Pt 3. Mgr 2 stated that if the CIWA protocol had been followed, the nurse may have had other interventions that might have changed the outcome for Pt 3. Mgr 2 stated the patient may have needed lorazepam, it would depend on the CIWA score, but the nurse did not re-evaluate to see if it was greater than 10 at any time after 7:12 p.m. Mgr 4 stated at the time RN 2 reported that Pt 3 did not want her heart monitor on at 10:46 p.m., she should have been assessed per the protocol, because “maybe the patient’s CIWA score was already increasing at that point. That would have been the time for another assessment. The patient was being uncooperative, which could be a sign of agitation.” Mgr 2 stated the patient’s vital signs were done at midnight by RN 2, but RN 2 didn’t notify the doctor about the increased heart rate, agitation and being disconnected from the heart monitor. Mgr 2 stated the heart monitor order was never discontinued. The nurse note from RN 2 dated 4/14/24 at 12:20 a.m. indicated, “ ...End of shift summary: maintained on CIWA monitoring, refused remote telemetry monitoring MD aware, continue with plan of care, hourly rounding ...” Mgr 2 stated the night shift ended at 07:30 a.m., not at 12:20 a.m., and she did not know why RN 2 wrote an end of shift summary halfway through the shift. During a concurrent interview and record review on 4/24/24 at 8:05 a.m. with RN 2, RN 2 stated she had worked at this facility for about 5 years. RN 2 remembered Pt 3. RN 2 stated she received report from RN 1 and made rounds on her patients. She recalled doing the CIWA assessment on this patient, and her score was an 8 so she did not need to give medication. RN 2 stated the CIWA protocol is used when patients are alcoholics. RN 2 stated lorazepam is administered if the scoring indicated it is needed. RN 2 stated she knew she needed to do one more CIWA assessment for this patient, but she got busy with other patients, and she did not get around to doing the third CIWA assessment. RN 2 stated she had a total of four patients, and it was not a heavy assignment. RN 2 stated the patient was placed on telemetry monitoring because of her electrolytes, she needed her heart to be monitored because her potassium was low, but she would not keep the monitor on. “I called the doctor, and she said it was okay.” RN 2 stated “Low potassium can cause arrythmias (irregular heart rate or rhythm) that’s why we have to replace it. There was not an ongoing potassium order.” RN 2 stated Pt 3’s blood was drawn on 4/14/24 at 4 a.m. and her K+ level was 2.1, and also her sodium phosphate was low. “I notified the on-call doctor when I got the results.” RN 2 stated the patient was agitated, frequently trying to get out of bed. “We would help her back to bed, she was standing up at the bedside, she was very agitated, pulling at her monitor. She just didn’t listen. She said she couldn’t sleep. I had to change her because she had a huge bowel movement. She seemed not to care that she was laying in it. She said she wanted to go home. I asked why she wanted to go when she was still so sick. She said she had a lot of laundry to do.” In hindsight, RN 3 says she thinks those actions sound like alcohol withdrawal. “I should have checked in with the doctor.” RN 3 stated the last time she saw Pt 3 before she coded was when she restarted her intravenous line (IV) at about 7:15 a.m. RN 3 stated during the IV start, Pt 3 did not respond verbally, “she just moaned and fell back to sleep. I thought she was just really tired.” During an interview on 4/24/24 at 8:30 a.m. with RN 1, RN 1stated she remembered Patient 3. She received report from the ED nurse, including Pt 3’s low K+ level and medications given in the ED. She stated she gave the last dose of K+ to Pt 3. RN 1 stated Pt 3 was on telemetry monitoring because of electrolyte imbalance, including low K+. RN 1 stated, “That (low K+) can mean there’s something going on with their heart, with their muscles, any number of things.” RN 1 stated she returned the next morning and was again assigned to care for Pt 3. When she went to see the patient with RN 2, Pt 3 was sleeping, and RN 2 stated she needed to restart her IV so she could receive IV K+. RN 1 stated right after she received report, she saw MD 9 come out of the room stating Pt 3 was coding. RN stated MD 9 and several nurses responded immediately, then the Code Blue team (designated staff who respond to all life-threatening events) arrived quickly. Pt 3 was taken to intensive care unit (ICU). During a concurrent interview and record review on 4/23/24 at 10:45 a.m. with MD 8, MD 8 stated she remembered Pt 3 and saw her twice in ED and recalled Pt 3 was admitted with Alcohol Withdrawal Disorder and severe electrolyte derangement (not within normal range.) MD 8 stated she started to “aggressively treat her electrolytes.” MD 8 stated Pt 3 was having pain from the IV K+, so she changed the order to PO K+. MD 8 stated, “that was the end of what I heard about her in the ED. MD 8 stated “it’s unclear how much of the IV potassium we were able to get into her, because the IV line was hurting her, so we stopped the infusion and changed to the oral form. MD 8 stated she signed out and left the facility at around 6:00 or 7:00 p.m., but she responded to a message from the Pt 3’s nurse around 7:30 p.m. that night saying Pt 3 had headache and neck stiffness. “We did a head CT (computerized tomography, a scan to see if there are any brain injuries) and I knew that was negative.” MD 8 stated she instructed the nurse to do warm compresses to Pt 3’s neck. MD 8 stated all of her notes were in the medical record for Pt 3, so the oncoming doctors could read what she had written and what medications had been given and the lab results. MD 8 stated she returned the next morning and reviewed Pt 3’s chart and saw that she was no longer on the heart monitor and that her K+ was still very low, and her platelets (blood cells that help blood clot) were also very low. MD 8 stated she went to see the patient in her room and could not wake her up, and she had foam around her mouth. MD 8 called a code blue and started emergency treatment. Pt 3 was then transferred to intensive care. During a concurrent interview and record review on 4/23/24 at 11:00 a.m. with MD 9, MD 9 stated took over care for Pt 3 at around 7:00 p.m. on 4/13/24. She stated she had access to Pt 3’s EMR and could see her medications and lab results. MD 9 stated she got a message on 4/13/24 at around 8:12 p.m. from Pt 3’s nurse (RN 2) indicating patient was asking for sleeping pills, so she ordered melatonin (a hormone that aids in sleep.) MD 9 stated she got another message from RN 2 around 10 p.m. indicating Pt 3 kept removing her [heart monitor] leads. “I said that’s fine.” MD 9 stated RN 2 did not indicate that Pt 3 was showing signs of increased agitation. MD 9 stated at about 5 a.m. she received a message that Pt 3’s K+ and phosphorus results were critically low, with both electrolytes measuring 2.1. MD 9 stated she ordered IV K+ and phosphorous (another essential electrolyte) because Pt 3 did not improve with the PO medication the day before. MD 9 stated she did not go to the bedside to observe the patient at any time during the night. MD 9 stated, “I wasn’t thinking about agitation at that point or that she needed another CIWA assessment.” During a concurrent interview and record review on 4/19/24 at 11:20 a.m. with the Director of 2 West Medical (Dir 1), Dir 1 stated, “The second dose of oral K+ 40 mEq was given right after she [Pt 3] got to 2 West at 6:05 p.m. (that was an ED order). There was no K+ ordered for her [Pt 3] inpatient stay until 4/14/24 when her morning lab results labs came back at 5:25 a.m., and RN 2 sent a message to MD 9. Dir 1 stated the K+ was drawn as part of a CMP (comprehensive metabolic panel - a group of blood tests that include electrolytes) at 4:12 a.m., resulted (completed in the lab) at 4:42 a.m. showing a K+ level of 2.1 The Clinical Laboratory Specialist called RN 2 on 4/19/24 at 5:25 a.m. with the results. RN 2 then sent a message to MD 9 at 5:31 a.m., and MD 9 ordered IV K+ for Pt 3. Dir 1 stated there is no indication that MD 9 came to the bedside to see the patient. During a concurrent interview and record review on 4/24/24 at 12:30 p.m. with MD 10, MD 10 stated, “I saw her (Pt 3) in the ED, and she was alert. We asked them (the ED nurses) to give the PO order then repeat. I think she had received a lot of K+ IV before that. I would expect her to come up to 3.5 (back into normal range for K+). Maybe that’s why they didn’t recheck the levels until the next morning.” MD 10 stated admission orders are to be carried out on the floor, even if they are written in the ED. The order for K+ was written in the ED by MD 8. MD 10 stated once we see the patient any changes in the clinical status should get updates from the RN. She received quite a lot of K+ in the ED. When the 2.2 result came back and they ordered 40 mEq of K+ x 2 (two doses) at 3:57 p.m. then again at 6:05 p.m. Normally after that amount of K+ has been given there would be an order for repeat the lab draw to check her levels 2 or 3 hours after the last dose. MD 10 stated. “she wasn’t a high cardiac risk,” then stated, “a potassium level of 2.2 is at high-risk patient of cardiac event, that’s why we replaced the potassium so aggressively.” MD 10 stated, “Any patient with a change in mental status should be seen by a provider, but I don’t think that was communicated.” MD 10 stated the information about the patient’s clinical condition was available to MD 9 if she had gone into the chart to read the notes. MD 10 stated. “[MD 9] is a first-year intern. If the nurse and the MD had talked by phone, maybe they would have communicated better, and the MD would have understood that the patient was agitated.” During an interview on 4/25/24 10:00 a.m. with the CMO, CNO, and DQ. Pt 3 was discussed. The CMO stated, “if the patient refusing the monitor, an MD should have gone to see the patient to have a dialogue.” The CMO stated if the patient was still refusing, talk about the reasons why the monitor is needed for their safety. A patient with very low K+ is at risk and needs to be monitored closely. The CMO stated, “When you [any MD] order labs, you are responsible to follow up on those labs. The MD responsible for the patient (Pt 3) should have been aware of how much K+ she had received and should have followed up with repeat lab draws to make sure the levels are coming up, and if not, they would most likely order more K+ to be given. The doctors all have access to that information in the patient’s EMR. The CNO stated the nurse should have talked to the doctor about Pt 3’s agitation, because the doctor may have ordered lorazepam and may have ordered repeat K+ lab tests. The CNO stated “the nurses should have been doing the CIWA protocol as ordered. I expect nurses to follow orders and protocols.” The CNO stated nurses should look at their patients’ lab results during handoff and discuss issues. If they were concerned that Pt. 3’s K+ was low with no order to continue giving the medication, they should have called the doctor. During a concurrent interview and record review with RN 1 the “Nursing Note” dated 4/14/2024 at 10:56 a.m. was reviewed. The “Nursing Note” indicated, “code blue was called overhead for this patient around 7:45 AM. Patient was found with foam on her mouth and gurgling sounds not responsive according to MD 8 who went in to see the patient. No pulse was felt on the patient and code blue was activated. Patient received CPR, meds, was intubated and transferred to ICU. MD 8 called to update patient’s mother who is patient’s decision maker as well, according to patient’s interview yesterday.” During a review of Pt 3’s “Progress Notes” dated 4/14/24 at 8:17 a.m. by MD 8 indicated, “Brief Note: I received sign out this morning that patient had taken off her telemetry leads and was not allowing them to be put back on with her pulse oximetry. I went to evaluate patient around 7:50 a.m. when I found patient unresponsive to auditory or painful stimuli. Patient had gurgling breath sounds and pulse was barely detectable. Subsequently called code blue and nursing staff immediately started CPR. Patient required multiple rounds of Epi (epinephrine - a powerful drug used during cardiac arrest) and CPR (cardiopulmonary resuscitation) with subsequent ROSC (Return of Spontaneous Circulation - heart started beating on its own again.) Called family and updated patient’s mother of current events and patient’s transfer to ICU. Signed out patient to doctor [name].” The hospital policy titled, “ ...Patient Care Policy and Procedure Critical Test and Critical Results and Values,” the document indicated, “ ... Purpose: to establish guidelines for the licensed caregiver on the management and notification of critical value test results ... Definition: critical value - a result displaying variance from normal as to represent a pathophysiologic state (illness) that is life threatening unless some action is taken within a very short time.” POLICY: ...9. Critical value results will be documented in the electronic health record by the licensed staff member and will include the critical value result, critical value result read back, name of physician notified, time physician notified, and actions taken .... “Performance Improvement: 1. Performance improvement data to evaluate the timeliness of reporting of critical results of tests and diagnostic procedures are collected and reported to the data analysis committee, the quality council, and the quality evaluation committee of the board. Two. Appropriate actions are taken to improve, and ongoing monitoring will evaluate the effectiveness of actions taken. Appendix A: Laboratory Critical Values ...Potassium - <2.8 or > 6.2 mEq/L The hospital policy titled “Alcohol Withdrawal: Care of the Patient,” dated July 2022, indicated, “... Purpose: to provide guidelines for the care of a patient in alcohol withdrawal. Outcome: screening and ongoing assessment are used to manage symptoms of alcohol withdrawal ...Procedure: 2. B. RN assesses patient using clinical institute withdrawal assessment alcohol revised (CIWA-Ar) tool and provides medical intervention per CIWA-Ar criteria ... CIWA-Ar Measuring Severity of Withdrawal ... Score 7-11 Assess q (every) 1 hour ... [administer] 2 mg. [Brand name]IV (intravenously - in a vein) or PO [by mouth].”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to develop a program to analyze indicators to improve health outcomes when there was no process in place to review and analyze quality indicators across the hospital. Data was collected in some individual departments, but the information was not reported up to the Quality Department for review and analysis. This failure resulted in the hospital not identifying and acting on critical incidents that could affect all inpatients’ health and well-being. Findings: During a concurrent interview and record review on 4/18/24 at 8:45 a.m. interview with the Director of Quality (DQ) the Quality Assurance and Performance Improvement (QAPI) Plan was reviewed. The DQ stated, “I’m going to be honest with you. We have a plan that has been developed, but it hasn’t been approved or implemented yet.” The DQ stated they have not been meeting as a group to review and analyze quality indicators or department projects. The DQ stated the Emergency Department has a robust project they have been working on, but they are the only department that has been reporting consistently. The DQ stated she just started to work at this facility last month, and the documentation prior to her arrival was not organized in a way that she would consider a QAPI program. She stated the hospital Quality Committee has not met for a long time and she could not produce minutes for any meetings. During a concurrent interview on 4/26/24 at 10:00 a.m. with the hospital leadership team, the CMO stated he was present in August 2023 when the California Department of Public Health (CDPH) identified similar concerns with the hospital’s Quality Assurance and Performance Improvement (QAPI) Program.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 45977 Based on interview and record review, the hospital failed to develop and keep current care plans for three of 10 patients in accordance with the policy “Patient Care Policy and Procedure - Documentation”. The primary care needs related to safety for Pts 6, 15 and 19 were not assessed and developed and not documented in the patients’ care plans. This failure had the potential to result in Patient 6, 15, and 19’s care needs going unmet. Findings: 1. During a concurrent interview and record review of Pt 6’s electronic health record (EHR- digital collection of medical information) on 4/18/24, at 12:40 p.m., Pt 6’s “History and Physical (H&P -- the formal document that physicians produce through the interview with the patient, the physical exam, and the summary of the testing either obtained or pending)”, dated 4/16/2024 at 8:05 a.m. and “Education [Nursing Care Plan]”, dated 4/16/2024, were reviewed with the Director of Medical/Surgical (Dr1) and Practice Coordinator, 2 West (PC1). Pt 6’s H&P indicated Pt 6 was brought to the hospital “with a past medical history significant for generalized anxiety disorder [mental health condition that causes fear, a constant feeling of being overwhelmed and excessive worry about everyday thing], ADHD [Attention Deficit Hyperactivity Disorder -- differences in brain development and brain activity that affect attention, the ability to sit still, and self-control] and intolerance to multiple psychotropic medications [drug that affects how the brain works and causes changes in mood, awareness, thoughts, feelings, or behavior]; who was brought into us by ambulance secondary to hydroxyzine [drug that prevents the effects of a histamine (a bodily substance released during an allergic reaction)] overdose with suicidal ideation. The patient consumes approximately 14 tabs of unknown dosage ... She was initially put on 5150 [temporary, involuntary psychiatric commitment of individuals who present a danger to themselves or others due to signs of mental illness] secondary to suicidal ideation ... At this time patient will be kept for observation for suicidal ideation. ... Suicidal ideation ... One-to-one sitter [health care worker assigned to provide one to one nursing or observation care to an individual patient for a period of time] ...”. Pt 6’s “Education [Nursing Care Plan]” indicated, “ ... Acute Pain, ... Cognitive: Tissue Perfusion, Cerebral [education related to a stroke] ... First Dose Education ...” as the focused care problems for nursing interventions. Dir1 stated, the care plan does not address the major reason for the admission. Dir1 stated, there should be a focus in the nursing care plan that addresses the patient’s safety related to the suicide ideations. Dir1 stated nurses are expected to develop a care plan that matches and guides the care of the patient. 2. During a concurrent interview and record review on 4/18/24, at 9:15 a.m., with Manager of Intensive Care (Mgr 4), Pt 15’s Cardiology Consult (a note from a physician who specializes in heart conditions) and Pt 15’s Plan of Care were reviewed with the Mgr 4. The Cardiac Consult, dated 3/31/2024 at 3:02 p.m., indicated Pt 15 was a 77-year-old woman who came into the Emergency Department (ED) on 3/30/24 at 5:47 with pneumonia (an infection of one or both of the lungs caused by bacteria) and was admitted to the hospital. The cardiologist was consulted 3/31/24 at 3:02 p.m. The Cardiology Consult note indicated, “ ...Known history of afib (atrial fibrillation - the upper chambers of the heartbeat irregularly which can lead to heart failure and stoke)) and diastolic heart failure (the heart can not properly fill with blood during the resting period between each beat. The document titled Care Plan was reviewed. The Care Plan did not include any plans related to Pt 15’s heart disease. Mgr 10 stated, “there should be a care plan that addresses cardiac output (amount of blood pumped by the heart minute) because she had a significant cardiac history.” 3. During a concurrent interview and record review on 4/18/24 at 1:50 p.m, with Mgr 7, Pt 19’s H&P dated 3/21/24 at 5:32 p.m., indicated Pt 19 was a 78-year-old man who came to the ED 3/21/2024 at 5:32 p.m. with a chief complaint of urinary retention (patient unable to urinate when bladder is full.) Pt 19 had a history of BPH (benign prostatic hyperplasia - the prostate gland enlarges and can block the urine stream,) CKD stage IV (severe kidney disease,) hypotension (low blood pressure) and type 2 diabetes (common condition that causes the level of sugar (glucose) in the blood to become too high).The document titled Care Plan was reviewed. The Care Plan did not include any plans related to Pt 19’s urinary retention, kidney disease, or diabetes. Mgr 7 stated this care plan is incomplete. It should include interventions for urinary retention and for diabetes, because the main reason he came to the hospital was for urinary retention. During an interview on 4/26/24, at 10:10 a.m., with the Chief Nursing Officer (CNO) and the Quality Director (QD) and the Chief Medical Officer (CMO), care plans for Pt’s 6. 15, and 19 were reviewed. The CNO stated, the nursing care plan should address the main complaint for admission. The CNO stated, the nursing care plan should address the main care needs of the patient. The CNO stated, the nurses are expected to follow the policy to documenting and updating the care plan. During a review of the facility policy and procedure (P&P) “”Patient Care Policy and Procedure - Documentation”, dated 10/2022, the P&P indicated, “ ... lnterprofessional Plan of Care (IPOC) is initiated and updated within the first 4 hours of patient’s arrival to the unit and reviewed once a shift. A Problem Specific IPOC and a Transitional Care IPOC are initiated on all inpatients. ...” The “Lippincott Manual of Nursing Practice 10th Edition,” dated 2014, page 16-17 indicated, “ Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient’s chart with clear, concise statements of the nurse’s decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 40644 45977 Based on observation, interview, and record review the hospital failed to follow the following policies and procedures when: 1. Three of five patients sampled (Patient (Pt) 1, Pt 23, and Pt 24) had epidurals (an injection in your back to stop you feeling pain in part of your body) placed and the hospital policy was not followed. These failures resulted in Pt 1’s baby fetal heart tones (FHT) not being monitored appropriately and possibly a contributing factor in the Pt 1’s baby’s death and placed both Pt 23 and Pt 24 at risk of a possible adverse reaction to having their epidurals removed without proper monitoring. 2. One of 3 sampled patients (Pt 3) was not assessed for alcohol withdrawal symptoms and a low serum potassium (an electrolyte in the body that is important for the function of nerves and muscles -- normal value 3.6 to 5.2 mmol/L (millimoles per liter)) laboratory (lab) value and was not addressed with follow up and more analysis of the clinical condition of the patient. These failures resulted in Pt 3’s not being monitored appropriately and possibly a contributing factor in the Pt 3’s death. 3. Two of 10 sampled patients (Pt 26 and Pt 27) had orders for telemetry monitoring and monitoring was not done appropriately per the hospital policy. These failures place Pt 26 and Pt 27 at risk of not having their heart rhythm monitored and thus placing them at risk of having irregular rhythms affecting their health. 4. One of one certified registered nurse anesthetist (CRNA 1) was observed placing an epidural in Pt 4 and not performing proper hand hygiene when CRNA 1 was seen removing dirty gloves and then placed on sterile gloves without performing hand hygiene in-between. This failure placed Pt 4 at risk of infection in Pt 4 epidural site. 5. One of 3 patients sampled (Pt 2) had a low serum glucose (sugar in the blood - normal value 70 to 100 mg/dL (milligrams per deciliter)) lab value and was not addressed with follow up and more analysis of the clinical condition of the patient. This failure had the potential to miss a change of condition for Pt 2. 6. One of 10 patients sampled patients (Pt 7) were not assessed or re-assessed for pain before or after the administration of pain medication. This failure had the potential to leave patients with uncontrolled pain and/or oversedation. 7. One of 4 sampled patients (Pt 10) did not have vital signs documented every four hours as required by the clinical condition of the patient. This failure had the potential to miss a change of condition for Pt 10. 8. One of 10 sampled patients (Pt 25) had two consents for procedures/surgeries that were not signed and or witnessed appropriately per the hospital policy. These failures placed Pt 25 at risk of having procedures performed without his consent. Because of the serious actual harm to Patient 3 when nurses did not follow hospital policies and procedures and not to follow up on critical labs Immediate Jeopardy (IJ) situation was called on 4/19/24 at 6 p.m., under Code of Federal A 0398 §482.42 in the presence of the President and Market Leader, the Chief Nursing Officer, The Chief Medical Officer, and the Director of Quality were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable plan of removal to address the IJ situation. Plan of removal was accepted on 4/22/24 at 3:30 p.m. Survey team’s onsite observations and interviews validated the hospital implemented appropriate corrective actions and the IJ was removed onsite on 4/22/24 at 5:00 p.m. in the presence of the Director Quality and the Manager of Quality and Accreditation. Following the IJ removal, the facility remained in substantial non-compliance. Findings: 1. During a review of Pt 1’s face sheet, dated 4/19/23, Pt 1’s face sheet indicated Pt 1 was a 36-year-old female who was admitted on 3/14/24 for the following diagnosis of Normal labor. During a review of Pt 1’s “OB H&P (Obstetrics [the branch of medicine and surgery concerned with childbirth and the care of women giving birth] History & Physical)” dated 3/14/24 at 6:59 p.m., the H&P indicated, “ ... 36 y.o. (year old) G4P3003 (gravida- number of pregnancies; para - number of live births) @ (at) 40w2d (40 weeks 2 days) admitted due to active labor (your cervix will dilate from six centimeters (cm) to ten cm). Pt was brought quickly to the labor room and an epidural (an anesthetic delivered through a catheter (small tube) into a potential space outside the spinal cord called the epidural space) was placed. Once the patient was calm, the nurses were able to place her baby on the monitor. No fetal heart tones were found. Leopold’s (maneuvers used to palpate/determine the position and presentation of the baby) were performed and no fetal movement noted. A call was made to the OBED (Obstetrics Emergency Department) doctor and a beside Sono (sonogram- visual image produced from an ultrasound) was performed, and no cardiac activity was noted. This was the first time I [Laborist - MD2] was notified the patient was on the floor ... I was called to the bedside in my role as an OBED Laborist to assess an OB urgent issue, the inability to find fetal heart tones. This was the first time I was notified that the patient was admitted for active labor. Upon my arrival, the room was full of nursing staff, approximately 10 nursing staff members and the anesthesiologist, [name - MD7] ...” During a concurrent interview and record review on 4/11/24, at 3 p.m., with Registered Nurse (RN) 4, Pt 1’s electronic health records (EHR) for her admission on 3/14/24 was reviewed. RN 4 stated she was the primary OB ED nurse for Pt 1 on 3/14/24 Pt 1 arrived in the OBED and presented in active labor, dilated to 6 cm (active stage of labor), and having painful contractions. RN 4 stated she never contacted the in-house OB ED physician who was covering for Pt 1’s obstetrician. RN 4 stated she knew the in- house physician was in the operating room (OR) in a c-section (the surgical delivery of a baby through a cut (incision) made in the birth parent’s abdomen and uterus) and did not want to disturb her, so she put in the “telephone orders with readback” knowing that this was not true. RN 4 stated she did not get admitting orders to include the epidural orders from the doctor and did not read them back to anyone and she knew this was wrong. RN 4 stated she knew she could call into the ORand either speak with the doctor or the nurse and relay that this patient was here, and she needed orders, but she just did not do that. RN 4 stated she moved Pt 1 up to Labor and Delivery (L&D) and recalls giving report, but it did not include the reviewing the fetal heart rate monitor strip which reflected a category 2 tracing (category 1 is normal baby heart rate 110-160 beats per minute, moving; category 2 minimal movement of baby’s heart rate still 110-160 but concerning- needs to be addressed). RN 4 stated, “it was inappropriate” of her to have not reviewed the fetal heart rate (FHR) strip with the nurse receiving Pt 1. During a record review of Pt 1’s Labor & Delivery Timeline dated 3/14/24 4:38 p.m. to 3/15/24 3:19 a.m., the timeline indicated on 3/14/24 at 5:09 p.m. “Event Labor Provider Notificaton Provider Name/Title: Provider in OR RN to enter orders User [name of RN 4] . onsite..” During an interview on 4/16/24, at 3:20 p.m., with the Interim OB Director (OBD), the OBD stated she expects that a RN would give report to the RN taking over the care of the patient. The OBD stated report would include a review of the fetal monitor strips. OBD stated a nurse should never indicate an order was obtained from a physician by telephone unless it was. OBED stated of course MD2 should have been notified of Pt 1, including the results of the fetal monitoring while Pt 1 was in the OB ED. The OBD stated fetal well-being should be established prior to the patient receiving an epidural. During a review of the hospitals policy titled, “Epidural Anesthesia for Labor Patients, Patient Controlled” date last reviewed 12/2021, the policy indicated, “PURPOSE: To provide guidelines to nursing staff in assisting the anesthesiologist with epidurals for Labor and Delivery, considering care for mother and unborn fetus. OUTCOME: The RN assists the anesthesiologist in the provision of epidurals for the OB patient ... PROCEDURE: 1. Pre-Procedure by RN: A. Apply Fetal Monitor [measures the heart rate and rhythm of your baby]and assess the FHR. B. Notify the obstetrician and obtain an order of patient request for epidural anesthesia [medical intervention that prevents patients from feeling pain]. C. Notify anesthesiologist assigned to labor and delivery ... 6. Contraindications to labor epidural: ... E. Fetal heart rate pattern requiring immediate birth ...” During a review of Pt 23’s face sheet, dated 4/23/24, Pt 23’s face sheet indicated Pt 23 was a 28-year-old female, admitted on 4/15/24 for a diagnosis of Normal labor. During a concurrent interview and record review on 4/23/24, at 9:30 a.m., with RN 5, Pt 23’s electronic health records (EHR) for her admission starting 4/15/24 was reviewed. RN 5 stated Pt 23 had an order for an Epidural. Pt 23’s flowsheets for lines, tubes and drains indicated two epidurals were placed, the first on 8/16/24 at 8:53 a.m. and removed the same time at 8:53 a.m., the second was placed on 8/16/24 at 8:58 a.m. and removed at 10:04 a.m. RN 5 stated Pt 23’s epidural removals are missing the documentation of the site and no mention of the tip of the catheter is intact after removal. RN 5 stated the expectation is this information would be documented after removal of the epidural. During a review of Pt 24’s face sheet, dated 4/23/24, Pt 24’s face sheet indicated Pt 24 was a 28-year-old female, admitted on 1/15/24 for a diagnosis of Normal labor. During a concurrent interview and record review on 4/23/24, at 10:14 a.m., with Interim Nurse Manager (RNM) 1, Pt 24’s EHR for her admission starting 1/15/24 was reviewed. RNM 1 confirmed Pt 24 had an order for an epidural to be placed and per Pt 24’s flowsheets for lines, tubes, and drains indicated an epidural was placed on 1/16/24 at 12:04 a.m. and was removed at 10 a.m. the same day and no documentation of the site and no mention of the tip of the catheter being intact after removal. RNM 1 stated the expectation after an epidural is removed is that the site is assessed and documented every shift and the risk to the patient if this is not done is possible site infection and possible leak of spinal fluid causing headaches. During a review of the hospitals policy titled, “Epidural Anesthesia for Labor Patients, Patient Controlled” date last reviewed 12/2021, the policy indicated, “PURPOSE: To provide guidelines to nursing staff in assisting the anesthesiologist with epidurals for Labor and Delivery, considering care for mother and unborn fetus. OUTCOME: The RN assists the anesthesiologist in the provision of epidurals for the OB patient ... PROCEDURE: ... 5. Discontinuing the epidural catheter: A. An RN may discontinue the epidural catheter per order. 1. The RN needs to have demonstrated competency on removal of epidural catheter. 2. Refer to Lippincott Procedures for epidural catheter removal ... 4. Notify anesthesiologist a. If any signs of infection are present. b. The catheter tip is either frayed or not intact. c. Leaking of excess fluid from the epidural site saturating the bandage. d. Patient exhibits prolonged recovery or decreased mobility or sensation in her extremities. 5. Document a. Assess the insertion site for tenderness, drainage, redness, or irritation. b. Date and time of removal of catheter and if tip intact ...” 2. During a concurrent interview and record review on 4/19/24 at 10:00 a.m. with Manager (Mgr) 4, the Electronic Medical Record (EMR) for Patient (Pt) 3 was reviewed. The facility document titled, “ED (Emergency Department) Provider Notes” dated 4/13/2024 at 5:03 a.m. by MD 12 indicated, “History of present illness: 36-year-old female with history of arthritis, anxiety, and depression BIBA (brought in by ambulance) with a complaint of AMS (altered mental status - not thinking or acting as usual.) ... history of heavy alcohol abuse but no known medical problems EMS (Emergency Medical Service) ... noticed numerous empty vodka and beer containers with patient appearing altered. Upon arrival I was able to appreciate patient with [symptoms of] withdrawing from alcohol ...initiate CIWA protocol (CIWA, Clinical Institute Withdrawal Assessment for Alcohol is an assessment tool used by doctors and nurses designed to evaluate the intensity of alcohol withdrawal symptoms and gives guidance on medication management based on the CIWA score.) During a review of MD 12’s orders dated 4/13/24 at 5:46 a.m., an order for a CIWA protocol was initiated with an expiration date of 4/16/24. During a concurrent interview and record review on 4/19/24 at 11:00 a.m. with the Director of Emergency Department (Dir 2), Dir 2 reviewed the laboratory (lab) blood test orders and stated the first blood draw on 4/13/24 at 6:03 a.m. for electrolytes (necessary minerals in blood and other body fluids that carry an electric charge) Pt 3’s potassium (K+ - one of the electrolytes) and results were called to MD 12 on 4/13/24 at 6:51 a.m. Pt. 3’s K+ level was reported as a dangerously low level of 2.0 (normal range is 3.5-6.2.) On 4/13/24 at 7:07 a.m., MD 12 ordered intravenous (IV) K+ to infuse at 10 mEq (milliequivalents - a unit of measure) in 100 mL fluid per hour over the next 8 hours. MD 12 also ordered 40 mEq of K+ to be given PO (by mouth) at the same time. At 3:04 p.m., Pt 3’s blood was redrawn and her K+ was 2.2, a very slight increase. At 3:57 p.m., MD 8 ordered, “Potassium chloride 40 mEq PO x 2 doses” and the first dose was given at 3:58 p.m. The EMR indicated, Pt 3 was then transferred from the ED to 2 West, an acute medical unit and was placed on a telemetry monitor (wires attached to the chest to monitor heart rate and rhythm.) Pt 3 arrived on 2 West at 5:51 p.m. and received her second dose of potassium chloride 40 mEq PO at 6:05 p.m., completing the order from the ED. Dir 2 was unable to find an order to recheck Pt 3’s K+ level until 4:03 a.m. the next morning on 4/14/24, and there was no order for additional K+ medication. On 4/19/24 at 10:32 a.m. during a concurrent interview and record review with the Manager of 2 West (Mgr 2) and Mgr 4, Mgr 2 reviewed the EMR for Pt 3 and stated no K+ was given after 6:05 p.m. on 4/13/24 and no repeat lab draw was done until 4:13 a.m. on 4/14/24. The CIWA order set (preapproved physician orders for patient’s experiencing alcohol withdrawal) was reviewed. The document titled, “Initiate CIWA-Ar assessment (Order 1021465339)” indicated, “Comments: Initiate CIWA-AR Assessment 1. If score is LESS than 10 (mild to no withdrawal symptoms); reassess every 2 hours x 2, then every 4 hours ...” Mgr 2 stated the nursing documentation indicated. Pt 3 had a CIWA score of 6 at 5:39 p.m., and a score of 8 at 7:12 p.m. There is no documentation indicating the nurses continued to assess Pt 3 and no further CIWA scores are in the chart. Mgr 2 stated with the score increasing from 6 at 5:39 p.m. to 8 at 7:12 p.m., the patient should have been reassessed two hours later at about 9:12 p.m. to ensure that the score was not continuing to increase. Mgr 2 stated there was no assessment at 9:12 p.m., and no further assessments throughout night. The nurses note dated 4/14/24 at 12:20 a.m. by RN 2 was reviewed. The nurses note indicated, “ ...End of shift summary: maintained on CIWA monitoring, refused remote telemetry monitoring MD aware, continue with plan of care, hourly rounding ...” Mgr 2 stated the night shift did not end until 07:30 a.m. on 4/14/24. The text message from Registered Nurse (RN) 2 sent to MD 9 on 4/13/24 at 10:07 p.m. was reviewed. The text message indicated, patient is “refusing to keep her remote telemetry monitor on, we had been replacing it back several times, but she keeps on removing it claiming that the leads make her itchy. She had been asking if she can go home tonight but we told her that it will be against medical advice. She said she’ll think about it and does not want the monitor on.” MD 9 responded with “okay that’s fine.” RN 2 checked Pt 3’s vital signs at midnight, and Pt 3’s heart rate was 107 beats per minute, a fast heart rate. Pt 3’s heart rate at 2:30 a.m. was 114 beats per minute. Pt 3’s MD was not contacted to inform regarding the high heart rate. Mgr 2 stated the CIWA assessments should have continued through the night, and pulling at the monitor and ahigh heart rate are signs of agitation for Pt 3. Mgr 2 stated that if the CIWA protocol had been followed, the nurse may have had other interventions that might have changed the outcome for Pt 3. Mgr 2 stated the patient may have needed lorazepam, it would depend on the CIWA score, but the nurse did not re-evaluate to see if it was greater than 10 at any time after 7:12 p.m. Mgr 4 stated at the time RN 2 reported that Pt 3 did not want her heart monitor on at 10:46 p.m., she should have been assessed per the protocol, because “maybe the patient’s CIWA score was already increasing at that point. That would have been the time for another assessment. The patient was being uncooperative, which could be a sign of agitation.” Mgr 2 stated the patient’s vital signs were done at midnight by RN 2, but RN 2 did not notify the doctor about the increased heart rate, agitation and being disconnected from the heart monitor. Mgr 2 stated the heart monitor order was never discontinued. The nurse note from RN 2 dated 4/14/24 at 12:20 a.m. indicated, “ ...End of shift summary: maintained on CIWA monitoring, refused remote telemetry monitoring MD aware, continue with plan of care, hourly rounding ...” Mgr 2 stated the night shift ended at 07:30 a.m., not at 12:20 a.m., and she did not know why RN 2 wrote an end of shift summary halfway through the shift. During a concurrent interview and record review on 4/24/24 at 8:05 a.m. with RN 2, RN 2 stated she had worked at this facility for about 5 years. RN 2 remembered Pt 3. RN 2 stated she received report from RN 1 and made rounds on her patients. She recalled doing the CIWA assessment on this patient, and her score was an 8 so she did not need to give medication. RN 2 stated the CIWA protocol is used when patients are alcoholics. RN 2 stated lorazepam is administered if the scoring indicated it is needed. RN 2 stated she knew she needed to do one more CIWA assessment for this patient, but she got busy with other patients, and she did not get around to doing the third CIWA assessment. RN 2 stated she had a total of four patients, and it was not a heavy assignment. RN 2 stated the patient was placed on telemetry monitoring because of her electrolytes, she needed her heart to be monitored because her potassium was low, but she would not keep the monitor on. “I called the doctor, and she said it was okay.” RN 2 stated “Low potassium can cause arrythmias (irregular heart rate or rhythm) that’s why we have to replace it. There was not an ongoing potassium order.” RN 2 stated Pt 3’s blood was drawn on 4/14/24 at 4 a.m. and her K+ level was 2.1, and also her sodium phosphate was low. “I notified the on-call doctor when I got the results.” RN 2 stated the patient was agitated, frequently trying to get out of bed. “We would help her back to bed, she was standing up at the bedside, she was very agitated, pulling at her monitor. She just didn’t listen. She said she couldn’t sleep. I had to change her because she had a huge bowel movement. She seemed not to care that she was laying in it. She said she wanted to go home. I asked why she wanted to go when she was still so sick. She said she had a lot of laundry to do.” In hindsight, RN 3 says she thinks those actions sound like alcohol withdrawal. “I should have checked in with the doctor.” RN 3 stated the last time she saw Pt 3 before she coded was when she restarted her intravenous line (IV) at about 7:15 a.m. RN 3 stated during the IV start, Pt 3 did not respond verbally, “she just moaned and fell back to sleep. I thought she was just really tired.” During an interview on 4/24/24 at 8:30 a.m. with RN 1, RN 1stated she remembered Patient 3. She received report from the ED nurse, including Pt 3’s low K+ level and medications given in the ED. She stated she gave the last dose of K+ to Pt 3. RN 1 stated Pt 3 was on telemetry monitoring because of electrolyte imbalance, including low K+. RN 1 stated, “That (low K+) can mean there’s something going on with their heart, with their muscles, any number of things.” RN 1 stated she returned the next morning and was again assigned to care for Pt 3. When she went to see the patient with RN 2, Pt 3 was sleeping, and RN 2 stated she needed to restart her IV so she could receive IV K+. RN 1 stated right after she received report, she saw MD 9 come out of the room stating Pt 3 was coding. RN stated MD 9 and several nurses responded immediately, then the Code Blue team (designated staff who respond to all life-threatening events) arrived quickly. Pt 3 was taken to intensive care unit (ICU). During a concurrent interview and record review on 4/23/24 at 10:45 a.m. with MD 8, MD 8 stated she remembered Pt 3 and saw her twice in ED and recalled Pt 3 was admitted with Alcohol Withdrawal Disorder and severe electrolyte derangement (not within normal range.) MD 8 stated she started to “aggressively treat her electrolytes.” MD 8 stated Pt 3 was having pain from the IV K+, so she changed the order to PO K+. MD 8 stated, “that was the end of what I heard about her in the ED. MD 8 stated “it’s unclear how much of the IV potassium we were able to get into her, because the IV line was hurting her, so we stopped the infusion and changed to the oral form. MD 8 stated she signed out and left the facility at around 6:00 or 7:00 p.m., but she responded to a message from the Pt 3’s nurse around 7:30 p.m. that night saying Pt 3 had headache and neck stiffness. “We did a head CT (computerized tomography, a scan to see if there are any brain injuries) and I knew that was negative.” MD 8 stated she instructed the nurse to do warm compresses to Pt 3’s neck. MD 8 stated all of her notes were in the medical record for Pt 3, so the oncoming doctors could read what she had written and what medications had been given and the lab results. MD 8 stated she returned the next morning and reviewed Pt 3’s chart and saw that she was no longer on the heart monitor and that her K+ was still very low, and her platelets (blood cells that help blood clot) were also very low. MD 8 stated she went to see the patient in her room and could not wake her up, and she had foam around her mouth. MD 8 called a code blue and started emergency treatment. Pt 3 was then transferred to intensive care. During a concurrent interview and record review on 4/23/24 at 11:00 a.m. with MD 9, MD 9 stated took over care for Pt 3 at around 7:00 p.m. on 4/13/24. She stated she had access to Pt 3’s EMR and could see her medications and lab results. MD 9 stated she got a message on 4/13/24 at around 8:12 p.m. from Pt 3’s nurse (RN 2) indicating patient was asking for sleeping pills, so she ordered melatonin (a hormone that aids in sleep.) MD 9 stated she got another message from RN 2 around 10 p.m. indicating Pt 3 kept removing her [heart monitor] leads. “I said that’s fine.” MD 9 stated RN 2 did not indicate that Pt 3 was showing signs of increased agitation. MD 9 stated at about 5 a.m. she received a message that Pt 3’s K+ and phosphorus results were critically low, with both electrolytes measuring 2.1. MD 9 stated she ordered IV K+ and phosphorous (another essential electrolyte) because Pt 3 did not improve with the PO medication the day before. MD 9 stated she did not go to the bedside to observe the patient at any time during the night. MD 9 stated, “I wasn’t thinking about agitation at that point or that she needed another CIWA assessment.” During a concurrent interview and record review on 4/19/24 at 11:20 a.m. with the Director of 2 West Medical (Dir 1), Dir 1 stated, “The second dose of oral K+ 40 mEq was given right after she [Pt 3] got to 2 West at 6:05 p.m. (that was an ED order). There was no K+ ordered for her [Pt 3] inpatient stay until 4/14/24 when her morning lab results labs came back at 5:25 a.m., and RN 2 sent a message to MD 9. Dir 1 stated the K+ was drawn as part of a CMP (comprehensive metabolic panel - a group of blood tests that include electrolytes) at 4:12 a.m., resulted (completed in the lab) at 4:42 a.m. showing a K+ level of 2.1 The Clinical Laboratory Specialist called RN 2 on 4/19/24 at 5:25 a.m. with the results. RN 2 then sent a message to MD 9 at 5:31 a.m., and MD 9 ordered IV K+ for Pt 3. Dir 1 stated there is no indication that MD 9 came to the bedside to see the patient. During a concurrent interview and record review on 4/24/24 at 12:30 p.m. with MD 10, MD 10 stated, “I saw her (Pt 3) in the ED, and she was alert. We asked them (the ED nurses) to give the PO order then repeat. I think she had received a lot of K+ IV before that. I would expect her to come up to 3.5 (back into normal range for K+). Maybe that’s why they didn’t recheck the levels until the next morning.” MD 10 stated admission orders are to be carried out on the floor, even if they are written in the ED. The order for K+ was written in the ED by MD 8. MD 10 stated once we see the patient any changes in the clinical status should get updates from the RN. She received quite a lot of K+ in the ED. When the 2.2 result came back and they ordered 40 mEq of K+ x 2 (two doses) at 3:57 p.m. then again at 6:05 p.m. Normally after that amount of K+ has been given there would be an order for repeat the lab draw to check her levels 2 or 3 hours after the last dose. MD 10 stated. “she wasn’t a high cardiac risk,” then stated, “a potassium level of 2.2 is at high-risk patient of cardiac event, that’s why we replaced the potassium so aggressively.” MD 10 stated, “Any patient with a change in mental status should be seen by a provider, but I don’t think that was communicated.” MD 10 stated the information about the patient’s clinical condition was available to MD 9 if she had gone into the chart to read the notes. MD 10 stated. “[MD 9] is a first-year intern. If the nurse and the MD had talked by phone, maybe they would have communicated better, and the MD would have understood that the patient was agitated.” During an interview on 4/25/24 10:00 a.m. with the CMO, CNO, and DQ. Pt 3 was discussed. The CMO stated, “if the patient refusing the monitor, an MD should have gone to see the patient to have a dialogue.” The CMO stated if the patient was still refusing, talk about the reasons why the monitor is needed for their safety. A patient with very low K+ is at risk and needs to be monitored closely. The CMO stated, “When you [any MD] order labs, you are responsible to follow up on those labs. The MD responsible for the patient (Pt 3) should have been aware of how much K+ she had received and should have followed up with repeat lab draws to make sure the levels are coming up, and if not, they would most likely order more K+ to be given. The doctors all have access to that information in the patient’s EMR. The CNO stated the nurse should have talked to the doctor about Pt 3’s agitation, because the doctor may have ordered lorazepam and may have ordered repeat K+ lab tests. The CNO stated “the nurses should have been doing the CIWA protocol as ordered. I expect nurses to follow orders and protocols.” The CNO stated nurses should look at their patients’ lab results during handoff and discuss issues. If they were concerned that Pt. 3’s K+ was low with no order to continue giving the medication, they should have called the doctor. During a concurrent interview and record review with RN 1 the “Nursing Note” dated 4/14/2024 at 10:56 a.m. was reviewed. The “Nursing Note” indicated, “code blue was called overhead for this patient around 7:45 AM. Patient was found with foam on her mouth and gurgling sounds not responsive according to MD 8 who went in to see the patient. No pulse was felt on the patient and code blue was activated. Patient received CPR, meds, was intubated and transferred to ICU. MD 8 called to update patient’s mother who is patient’s decision maker as well, according to patient’s interview yesterday.” During a review of Pt 3’s “Progress Notes” dated 4/14/24 at 8:17 a.m. by MD 8 indicated, “Brief Note: I received sign out this morning that patient had taken off her telemetry leads and was not allowing them to be put back on with her pulse oximetry. I went to evaluate patient around 7:50 a.m. when I found patient unresponsive to auditory or painful stimuli. Patient had gurgling breath sounds and pulse was barely detectable. Subsequently called code blue and nursing staff immediately started CPR. Patient required multiple rounds of Epi (epinephrine - a powerful drug used during cardiac arrest) and CPR (cardiopulmonary resuscitation) with subsequent ROSC (Return of Spontaneous Circulation - heart started beating on its own again.) Called family and updated patient’s mother of current events and patient’s transfer to ICU. Signed out patient to doctor [name].” The hospital policy titled, “ ...Patient Care Policy and Procedure Critical Test and Critical Results and Values,” the document indicated, “ ... Purpose: to establish guidelines for the licensed caregiver on the management and notification of critical value test results ... Definition: critical value - a result displaying variance from normal as to represent a pathophysiologic state (illness) that is life threatening unless some action is taken within a very short time.” POLICY: ...9. Critical value results will be documented in the electronic health record by the licensed staff member and will include the critical value result, critical value result read back, name of physician notified, time physician notified, and actions taken .... “Performance Improvement: 1. Performance improvement data to evaluate the timeliness of reporting of critical results of tests and diagnostic procedures are collected and reported to the data analysis committee, the quality council, and the quality evaluation committee of the board. Two. Appropriate actions are taken to improve, and ongoing monitoring will evaluate the effectiveness of actions taken. Appendix A: Laboratory Critical Values ...Potassium - <2.8 or > 6.2 mEq/L The hospital policy titled “Alcohol Withdrawal: Care of the Patient,” dated July 2022, indicated, “... Purpose: to provide guidelines for the care of a patient in alcohol withdrawal. Outcome: screening and ongoing assessment are used to manage symptoms of alcohol withdrawal ...Procedure: 2. B. RN assesses patient using clinical institute withdrawal assessment alcohol revised (CIWA-Ar) tool and provides medical intervention per CIWA-Ar criteria ... CIWA-Ar Measuring Severity of Withdrawal ... Score 7-11 Assess q (every) 1 hour ... [administer] 2 mg. [Brand name]IV (intravenously - in a vein) or PO [by mouth]. A research article from The Oxford Academic retrieved from https://doi.org/10.1093/alcalc/agad016 from March 2023 indicated, “ ...The estimated death rate from severe AWS (alcohol withdrawal syndrome) varies from 5% in treated cases to ... as high as 37% in untreated cases (Rahman and Paul, 2022), including deaths from Delirium Tremens (DTs), seizure, stroke, heart disease and other causes. From these figures, we estimate about 270,000 US deaths annually. One study notes a 37% death rate among DT cases within 8 years of the initial occurrence (Perala et al., 2010).” A professional article from Experimental and Clinical Cardiology titled, “Hypokalemia (low potassium) and Sudden Cardiac Death” dated 3/2020 indicated, “ ...Worldwide, approximately three million people suffer sudden cardiac death annually. These deaths often emerge from a complex interplay of substrates and triggers. Disturbed potassium homeostasis (all systems are balanced) among heart cells is an example of such a trigger. Thus, hypokalemia and, also, more transient reductions in plasma potassium concentration are of importance ...” 3. During a review of Pt 26’s face sheet, dated 4/23/24, indicated Pt 26 was 83-year-old male who was admitted on 4/15/24 for a diagnosis of syncope (temporary loss of consciousness caused by a fall in blood pressure) and collapse. During a review of Pt 26’s “Telemetry Monitoring for Arrhythmia Management” order, dated 4/15/24 start time 2:31 p.m. and expired on 4/17/24 at 2:07 p.m., order indicated, “ ... Indication for cardiac or telemetry monitoring: Arrhythmia (heart beats with an irregular or abnormal rhythm) Management ... Notify Provider for heart rate GREATER than 200 Notify Provider for heart rate LESS than 30 Notify Provider for (other) Persistent rate change in cardiac rhythm ...” During a review of Pt 26’s “Telemetry Monitoring for Arrhythmia Management” order, dated 4/17/24 start time 2:07 p.m. and canceled on 4/18/24 at 3:17 p.m. for Pt 26’s discharge, order indicated, “ ... Indication for cardiac or telemetry monitoring: Arrhythmia (heart beats with an irregular or abnormal rhythm) Management ... Notify Provider for heart rate GREATER than 200 Notify Provider for heart rate LESS than 30 Notify Provider for (other) Persistent rate change in cardiac rhythm ...” During a concurrent interview and record review on 4/23/24, at 2:55 p.m., with the Manager on Telemetry floor (Mgr) 5, Pt 26’s Flowsheet Data for Cardiac/Telemetry 4/15/24 -4/18/24 were reviewed. Mgr 5 stated Pt 26 was placed on Telemetry monitoring per the flowsheets on 4/15/24 at 9 p.m., the first cardiac rhythm (CR) is documented on 4/16/24 at 9:10 a.m. with no measurements (PR, QRS, and QT intervals- which will show if there are issues with the patient’s heart) documented, the second CR is documented on 4/17/24 at 7:15 a.m. with no measurements documented, the third CR is documented on 4/17/24 at 11:25 a.m. with no measurements. Mgr 5 stated the expectation is the registered nurse (RN) will review the patients CR strips twice a shift (each shift is 12 hours long) and will interpret and document the measurements in the patients’ chart. Mgr 5 stated based on Pt 26’s cardiac flowsheets the policy was not followed. During a review of Pt 27’s face sheet, dated 4/23/24, indicated Pt 27 was a 77-year-old male who was admitted on 4/8/24 for a diagnosis of requiring assistance with activities of daily living. During a review of Pt 27’s History and Physical (H&P), dated 4/9/24, indicated Pt 27 was admitted for weakness and diagnosed with COVID (corona virus- an infectious disease caused by the SARS-CoV-2 virus), with a medical history of anemia (low blood count), low potassium (electrolyte level - normal is 3.6 to 5.2 millimoles per liter (mmol/L)), Parkinson disease (a progressive disorder that affects the nervous system and the parts of the body controlled by the nerves), and chronic foley catheter (a semi-flexible plastic tube, one end is inserted into the bladder and the other end is attached to a bag that collects urine) use. During a concurrent interview and record review on 4/23/24, at 3:30 p.m., with the Manager of 3 Main Mgr 3, Pt 27’s Flowsheet Data for Cardiac/Telemetry 4/9/24 -4/21/24 were reviewed. Mgr 3 stated Pt 27 was placed on Telemetry monitoring per the flowsheets on 4/9/24 at 8 p.m., the first CR is documented on 4/11/24 at 7:59 p.m., second CR is documented on 4/11/24 at 9 p.m., third CR is documented 4/12/24 at 1:07 a.m., next CR is documented on 4/12/24 at 8:27 a.m. with no measurements, (1-2 p.m. missing), next CR is documented on 4/12/24 at 9 p.m. with no measurements, (1-2 a.m. missing), next CR is documented on 4/13/24 at 8:20 a.m. with no measurements, (1-2 p.m. missing), next CR is documented 4/13/24 at 7:20 p.m., next CR documented on 4/13/24 at 9 p.m. with no measurements, next CR is documented 4/14/24 at 1:15 a.m., next 4/14/24 at 7:56 a.m. with no measurements, (1-2 p.m. missing), next 4/14/24 at 7:19 p.m., next 4/15/24 at 1 a.m., (7-8 a.m. missing), next 4/15/24 at 5:21 p.m. with no measurements, (1-2 a.m. missing), next 4/16/24 at 9:50 a.m. with no measurements, (1-2 p.m. missing), next 4/16/24 at 7:42 p.m., next 4/17/24 at 2:58 a.m., next 4/17/24 at 7:34 a.m., next 4/17/24 at 1:26 p.m., next 4/17/24 at 9:41 p.m. with no measurements, next 4/18/24 at 2:25 a.m., (1-2 p.m. missing), next 4/18/24 at 7:56 p.m., next 4/19/24 at 2:15 a.m., next 4/19/24 at 9:45 a.m., next 4/19/24 at 1:18 p.m., next 4/19/24 at 7:35 p.m., next 4/20/24 at 1:58 a.m., (7-8 a.m. missing), (1-2 p.m. missing) next 4/20/24 at 7:16 p.m., next 4/21/24 at 1:11 a.m.. Mgr 3 stated the documentation and measurements for Pt 27’s telemetry strips should not be missing; the expectation is telemetry strips are reviewed and documented twice a shift. During an interview on 4/24/24 at 3:19 p.m., with RN 8, Pt 27’s electronic health records (EHR) for admission starting 4/8/24 was reviewed. RN 8 stated Pt 27 arrived in his room at approximately 6:20 p.m. on 4/9/24 and she recalls he was positive for COVID, and she changed him into a gown, remembering he had a foley catheter, he was a total assist and had wounds. RN 8 stated she called the monitor room to make sure Pt 27’s heart rhythm was being monitored, when the next shift came on at 7 p.m. she gave report to the oncoming nurse letting them know what Pt 27’s heart rhythm was and what needed to be completed. RN 8 stated the nurses are responsible for reviewing and documenting the rhythm strips every 6 hours for day shift at 8 a.m. and 1:30-2 p.m. and if they go into an irregular rhythm then they are responsible to review that and document it as well. RN 8 stated the monitor room will call the nurses if there are any issues with the patients’ rhythm. RN 8 stated Pt 27’s potassium level was low and that is why he was placed on telemetry monitoring. RN 8 stated that Pt 27 was not having any cardiac issues but with low potassium he was at risk. During an interview on 4/24/24, at 3:35 p.m., with RN 9, Pt 27’s EHR for admission starting 4/8/24 was reviewed. RN 9 stated he recalls taking care of Pt 27, Pt 27 was in for small bowel obstruction and hypokalemia (low potassium) and was on telemetry monitoring for the hypokalemia. RN 9 stated he believed he was responsible to look at Pt 27’s telemetry strips every 6 hours, “I try to aim at 8-9 a.m. when I am doing my assessment and then again around 2 p.m.”. RN 9 stated it was important to review the telemetry strips and measure the PR interval and QT intervals and hopefully prevent arrhythmias. RN 9 stated we no longer get physical paper strips they are now uploaded into the patients’ medical records, and we are supposed to look them up in the media files and interpret them but sometimes we get busy and do not interpret them. RN 9 stated when he gives hand off report to the next nurse, he does report the patient’s rhythm at that time. RN 9 stated it was important to review the patient’s telemetry strips because the patient can be at risk for going into an irregular rhythm. During a review of the hospital policy titled, “Telemetry Monitoring: Admission/Discharge/Triage of Telemetry and Remote Telemetry Patients” date last reviewed 7/2023, it indicated, “PURPOSE: To delineate responsibilities and expectations of staff caring for patients requiring telemetry monitoring and to provide guidelines for the utilization of telemetry monitoring. OUTCOME: To provide safe, consistent surveillance of patients requiring telemetry monitoring for the detection of possible cardiac rhythm disturbances. POLICY: ... 3. A licensed nurse (Licensed Vocational Nurse (LVN) or Registered Nurse (RN)) with rhythms recognition training or Monitor Observer Technician (MT) will monitor the cardiac rhythms of patients on continuous telemetry transmitters ... PROCEDURE: ... 4. Monitoring and Care - Licensed Nurse: A. Performed by a licensed nurse caring for telemetry patients or a licensed nurse with dysrhythmia recognition training caring for remote telemetry patients. i. Obtain/verify measurements (PR, QRS, QT), interpret rhythm strips, and documents interpretation and measurements in the patient’s chart on admission and every six (6) hours ... iii. A registered nurse (RN) with dysrhythmia recognition training is responsible for initial rhythm interpretation. A licensed vocational nurse (LVN) with dysrhythmia recognition training may interpret subsequent rhythm strips. If a change in rhythm occurs, the RN is responsible for final rhythm interpretation. Iv. In addition to routine rhythm strip collection, review rhythm strip and document in the EHR for these situations: 1) Admission/Discharge 2) Any change in rhythm or ectopy 3) Intravenous (IV) push cardiac drug administration. 4) Patient complaints of chest pain/pressure 5) Dizziness/syncopal episodes 6) Defibrillation/cardioversion ...” During a review of a professional reference titled, “Electrocardiographic manifestations in severe hypokalemia” dated 1/2020, indicated, “ ... Hypokalemia is one of the most common electrolyte disturbances in the clinic and it can increase the risk of life-threatening arrhythmias. Electrocardiographic (ECG waveform consists of P-wave (0.08-0.10 s), QRS interval (0.06-0.10 s), and T-wave (0.16 s)) characteristics associated with hypokalemia include dynamic changes in T-wave morphology, ST-segment depression, and U waves, which are often best seen in the mid-precordial leads (V2-V4). The PR interval can also be prolonged along with an increase in the amplitude of the P wave ...Hypokalemia is one of the commonly encountered electrolyte disturbances, and has the potential to increase the risk of arrhythmia.1-4 Hypokalemia is defined as a potassium level <3.5?mmol/L, moderate hypokalemia as a potassium level of <3.0?mmol/L, and severe hypokalemia as a potassium level <2.5?mmol/L. Diarrhea and diuretic therapy are responsible for most cases of hypokalemia in the clinic.2,5 The level of serum potassium is vital for regulating depolarization and repolarization of the myocardium, and hypokalemia can alter the cardiac action potential and result in abnormities of cardiac conduction.6 Additionally, the P pulmonale pattern is occasionally observed in patients with hypokalemia, and it is transient and concomitant.7,8 These changes are responsible for findings on a surface electrocardiogram (ECG) associated with hypokalemia. When potassium levels are <2.7?mmol/L, changes in the ECG include dynamic changes in T-wave morphology (T-wave flattening and inversion), ST-segment depression, and U waves, which are often best seen in the mid-precordial leads (V1-V4). Furthermore, high potassium levels precipitate potentially life-threatening dysrhythmias.9,10 Therefore, serum potassium levels in patients who experience arrhythmia need to be checked, especially when they have diuretic therapy or diarrhea ...” Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287199/ 4. During a review of Pt 4’s Face sheet dated, 4/24/24, the face sheet indicated Pt 4 was a 26-year-old female admitted on 4/24/24 with diagnosis of history of uterine scar from previous surgery, in for repeat Cesarean Section (the surgical delivery of a baby through a cut (incision) made in the birth parent’s abdomen and uterus). During a concurrent observation and interview on 4/24/24, at 1:02 p.m., with CRNA 1 and Interim Nurse Manager for L&D (RNM 1), Pt 4 was seen being escorted into OB OR 1 and helped onto the surgical table. Pt 4 was positioned to sit on the side of the table and circulating nurse was checking for fetal heart tones and then placed mom on oxygen saturation monitor and blood pressure monitoring. CRNA 1 entered OR 1 and reintroduced herself to Pt 4 and explained that she would be putting in the patient’s epidural. CRNA 1 was seen with clean blue gloves on touching Pt 4’s back and preparing her medications, CRNA 1 then removed her blue, now dirty gloves and put on a pair of off-white sterile gloves and continued to put in Pt 4’s epidural. RNM 1 stated CRNA 1 should have cleaned her hands after she removed her dirty gloves and prior to putting on her sterile gloves, this placed Pt 4 at risk of infection. During a review of the hospital’s policy titled, “Hand Hygiene” last revised date 11/2022, indicated, “PURPOSE: To establish hand cleansing guidelines which are consistent throughout the facility based on the Centers for Disease Control (CDC) and World Health Organization (WHO) guidelines for Hand Hygiene. OUTCOME: Direct transmission of any health care acquired infections will be minimized or eliminated. DEFINITIONS: Hand Hygiene: General term that references hand cleansing procedures, whether by hand washing with soap and water or use of an alcohol-based hand sanitizer ... PROCEDURE: Hand hygiene by Employees, doctors, licensed independent practitioners (LIP), volunteers, vendors, patients, and visitors ... 3. Examples of important times to perform hand hygiene: 1) Perform hand hygiene Before and After: a. Coming in physical contact with a patient b. Gloving and attending to a patient’s nasal or oral passages, dealing with excreta or secreta, handling patient equipment, sorting linen, cleaning, or collecting specimens c. Eating or drinking, applying cosmetics or lip balm, and handling contacts 2) Hand Hygiene Before: a. Preparing or serving meals, drinks, or tube feedings. b. Beginning of work shift c. Performing aseptic procedures d. Handling patient supplies and linens 3) Hand Hygiene After: a. Removal of personal protective equipment (including gloves) b. Contact with the patient’s environment c. Using the restroom d. Touching contaminated work surfaces e. Handling patient equipment f. Contact with trash or blood, blood products or Other Potentially Infectious Materials (OPIM), or any body fluid. g. Ending of work shift. h. Hand sanitizer should not be used when hands are visibly soiled or after contact with patient (or patient environment) that has an active or suspected Clostridium difficile (C-diff) infection. 4) Hand Hygiene should follow the principles of the World Health Organization (WHO) “5 Moments”. http://who.int/gpsc/tools/Five_moments/en ...” 5. During a review of Pt 2’s,”Hospitalist H&P [History and Physical”, dated 3/25/24, the note indicated, Pt 2 came to the emergency room, “HPI [History of Present Illness] ... 87 year old male BIBA [brought in by ambulance] sent from SNF [Skilled Nursing Facility] with history of myasthenia gravis [a disorder in which the body destroys the communicate between nerves and muscles, resulting in loss of muscle control and weakness] as well as hypotension [low blood pressure]. Per EMS [Emergency Medical Services], he cannot keep anything down, has a small decubitus ulcer [wound] on his buttocks but is not voicing any complaints. He reported he was having vision changes, a productive cough with mucous, and dizziness where he feels like he wants to pass out. He reported some trouble swallowing and has no appetite. Pt [Patient] also states that he does have a bladder infection ... He states that he recently took Prednisone (a medication that works on the immune system to help relieve swelling, redness, itching, and allergic reactions). Denies chest pain, SOB [short of breath], abd [abdominal] pain, and any other symptoms. ...he will be admitted for acute UTI [Urinary Tract Infection] and AKI [Acute Kidney Injury] ... “ During a concurrent interview and record review on 4/22/24, at 1:50 p.m., with the Nurse Manager of 3 West, (Mgr1), Pt 2’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), “Patient Care Timeline (PCF)”, and “electronic health records” (EHR), were reviewed for Pt 2’s encounter dated 4/8/2024. Mgr 1 stated Pt 2 had not been fed through his gastrostomy tube (GT) since 4/6/24. Mgr 1 stated the order to hold GT feedings was dated 4/6/24. The Mgr1 stated, Pt 2 had a serum glucose of 67 mg/dL on 4/8/24 at 5:01 a.m. The Mgr1 stated, the doctor was not notified about this result by the nurse and it was not documented in the chart. The Mgr1 stated, it is expected that nurses should contact the doctor about abnormal labs and document what they have done in the plan of care for the patient. During a concurrent interview and record review on 4/24/24, at 2:35 p.m., with the Registered Nurse of 3 West, (RN 2), Pt 2’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), “Patient Care Timeline (PCF)”, and “electronic health records” (EHR), were reviewed for Pt 2’s encounter dated 4/8/2024. The RN 2 stated, she had reviewed the labs for 4/8/24 for Pt 2 and had concentrated on the lab results of the “H&H” (Hemoglobin and Hematocrit (Measures of the number of Red Blood Cells; often. checked to rule out blood loss)) and overlooked the low glucose results for 4/8/2024. The RN 2 stated, the doctor should have been notified and any symptoms displayed by patient. The RN 2 stated, she would have recommended that the patient receive an order for Dextrose (medication that is concentrated sugar) intravenously (by vein through the blood system) and increase monitoring of the serum glucose. During an interview on 4/26/24, at 10:10 a.m., with the Chief Nursing Officer (CNO) and the Quality Director (QD) and the Chief Medical Officer (CMO), Pt 2’s care was reviewed. The CNO stated, nurses are expected to look at the labs of the patient when they receive report from the off going nurse. The CNO stated, she expected that the nurse call the doctor for closer monitoring of the glucose and interventions to address the patient’s condition and document it in the record her actions. During a review of the facility policy and procedure (P&P) “”Patient Care Policy and Procedure - Documentation”, dated 10/2022, the P&P indicated, “ ... The interprofessional team will document their assessment and evaluation of care based upon the plan of care and data collection. ... A complete review of systems is performed at the beginning of each shift to establish a baseline. Abnormal systems and/or deviations from the patient’s normal are documented as appropriate. ...” During a review of the California Board of Registered Nursing Professional Reference titled, “California Code of Regulations” undated, (https://rn.ca.gov) indicated, “... A registered nurse shall directly provide ... Ongoing patient assessments as defined in the Business and Professions Code, Section 2725(d). Such assessments shall be performed, and the findings documented in the patient ’ s medical record, for each shift and upon receipt of the patient when he/she is transferred to another patient care area ... RN is accountable for an ongoing comprehensive assessment that includes data collection, analysis, and drawing conclusions/making judgments in order to ... formulate diagnoses and update diagnoses formulate or change the plan of care ... decide on specific activities to implement the plan of care (immediate and long-term) ... prioritize and coordinate delivery of care delegate to nursing care competent staff to deliver required care ... anticipate discharge planning/teaching needs... advocate for the patient as needed ... RN uses scientific knowledge and experience to make clinical judgments about observed abnormalities and changes based on a series of complex, independent and collaborative decision making activities ... RN is responsible/accountable to see actual and potential patient needs/health problems are addressed and get recorded on the plan of care ... “ 6. During a concurrent interview and record review on 4/18/24, at 1:20 p.m., with the Director of Medical/Surgical (Dir1), Pt 7’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), “Pain Monitoring Flowsheet [PMF]”, and “electronic health records” (EHR), were reviewed for Pt 7’s admission dated 4/9/2024. The Dir1 stated, Pt 7 had an order for Hydromorphone IV (intravenous (IV) narcotic pain medication) 1 mg (unit of measurement- milligrams) every two hours as need for severe pain 7 out of 10. The PMF indicated, Pt 7 received 1 mg of Hydromorphone on 4/9/24 at 8:43 p.m., no reassessment of pain was documented. Pt 7 received 1 mg of Hydromorphone on 4/13/24 at 3:54 a.m., no reassessment of pain was documented. The PMF indicated a pain score of 8 out of 10 for 4/9/24 at 11:00 p.m., 4/9/24 at 11:11 p.m., 4/10/24 at 3:25 a.m., 4/10/24 at 8:40 a.m., 4/10/24 at 11:44 a.m., 4/10/24 at 8:23 p.m., 4/10/24 at 11:49 p.m., and 4/10/24 at 4:59 p.m.. and no pain medications/interventions were documented to address the pain. The Dir1 validated the missing reassessments and interventions for the elevated pain assessments. The Dir1 stated, the pain medications should be reassessed within 15 mins after giving IV medications and 1 hour with medications by mouth. The Dir1 stated, interventions and/or pain medications should have been given to the patient for the scores of 8. The Dir1, stated she expected nurses to treat patients’ pain and try to control the patients’ level of pain to what is acceptable to the patient. The Dir1 stated, nurses are expected to monitor patients for adverse reactions to pain medications. During a review of Pt 7’s,”HISTORY AND PHYSICAL [H&P],” dated 4/9/24, the “H&P” indicated, Pt 7 was admitted on 4/9/24, “Chief Complaint: Abdominal pain ... very pleasant 71 year-old gentleman with PMH [Previous Medical History] significant for stage IV bladder cancer, HTN [Hypertension (high blood pressure)], HLD [Hyperlipidemia (high lipids (fats) in the blood)], OSA [Obstructive Sleep Apnea], and chronic pain ... “ During an interview on 4/26/24, at 10:10 a.m., with the Chief Nursing Officer (CNO) and the Quality Director (QD) and the Chief Medical Officer (CMO), Pt 7’s care was reviewed. The CNO stated, pain should be addressed for a score of 8 and pain reassessments should have been done as per the policy. The CNO stated, nurses were expected to assess patient pain levels to help determine the effectiveness of the pain medications. The CNO stated, if nothing is ordered to treat pain levels greater than 5 then something should be ordered and nurses should address the pain of the patient to meet the patient’s pain goal and comfort levels. During a review of the facility policy and procedure (P&P) “Pain Management Guidelines”, dated 11/20, the P&P indicated, “ ... Patients are timely assessed/re-assessed for pain, educated on their treatment, and managed appropriately for complications. ... The Registered Nurse (RN) will evaluate for pain and teach the patient to score their pain and/or relief according to an appropriate/designated pain scale. ... Patients will be assessed for characteristics ... that increase their risk for over sedation and/or respiratory depression using standardized tools ... and monitored accordingly. This assessment will include prior opioid tolerance and intolerance based on previous history. ... Reassessment criteria will be used to evaluate and respond to the patient’s pain. ... Pain will be reassessed and documented 15 minutes after IV pain medicine administration and 1 hour after oral pain medicine administration. ...” 7. During a review of Pt 10’s,”Emergency Provider Note,” dated 4/15/24, the note indicated, Pt 10 came to the emergency room, “History of Present Illness ... 81 y/o [year-old] female with a h/o [history of] worsening R [right] elbow tendonitis [inflamed tissue that connects muscle to bone] returns to the ED [Emergency Department] a second time today due to difficulty ambulating with a walker at home due to worsening L [left] elbow pain, onset earlier today. Pt states she is unable to bear weight on walker due to L elbow pain. During a concurrent interview and record review on 4/23/24, at 1:11 p.m., with the Director of Emergency Services (Dir2), Pt 10’s “Face sheet” (provides demographics of the patient, name, date of birth, admission date, chief complaint), “Patient Care Timeline (PCF)”, and “electronic health records” (EHR), were reviewed for Pt 10’s encounter dated 4/15/2024. The Dir2 stated, Pt 10 was triaged to a ESI (Emergency Severity Index -- a 5-level emergency department triage algorithm that sorts patients into 5 groups from I (most urgent) to V (least urgent) based on predicted acuity and resource needs)) of a 3. The Dir2 stated, the vital signs (measurements of the body’s most basic functions) should have been done every 2 hours until stable and then every 4 hours after that if the patient is clinically stable. Pt 10 had remained clinically stable and the vital signs were ordered for every 4 hours. On 4/16/24 at 7:00 p.m., the vital signs were Temperature: 98.1 F.; Heart Rate: 72; Respirations: 17; Blood Pressure 138/61 mm (millimeters) Hg (Mercury); SpO2 (oxygen saturation - a measurement of how much blood is in the oxygen): 99 %. The next vital signs were documented on 4/17/24 at 4:04 a.m., Temperature: 98.6; Heart Rate: 63; Respirations: 19; Blood Pressure: 133/58 mm HG; SpO2: 96%. The Dir2 stated, the nurse should have obtained vital signs around midnight to 1 a.m. for the patient’s condition. The Dir2 stated, the nurses should monitor the patients to ensure no change of condition has occurred and data is obtained to update the plan of care. During an interview on 4/26/24, at 10:10 a.m., with the Chief Nursing Officer (CNO) and the Quality Director (QD) and the Chief Medical Officer (CMO), Pt 10’s care was reviewed. The CNO stated, the vital signs should be as frequent as to match the clinical condition and the nurses should follow the policy related to the triage of patients and monitoring. The CNO stated, it is expected that nurses should take the vital signs based on the ESI assigned and ensure the care and vital signs match the care that is appropriate to the patient’s condition. During a review of the facility policy and procedure (P&P) “EDDAD”, dated 2/2024, the P&P indicated, “ ... To provide care in a safe and consistent manner for patient’s receiving care in the emergency department. ... ESI Level 3: Document every 2 hours. If normal vital sign trends or clinically stable (a minimum of 2 sets of vital signs within normal limits) document at least every 4 hours.. ...” 8. During a review of Pt 25’s face sheet, dated 4/24/24, Pt 25’s face sheet indicated Pt 25 was admitted on 2/26/24 for the following diagnosis of abdominal pain, unspecified abdominal location. During a review of Pt 25’s History and Physical (H&P), dated 3/24/24 at 2:17 p.m., the H&P indicated, “[name of Pt 25] is a 46 y.o. (year old) man with diabetes (group of diseases that result in too much sugar in the blood), currently admitted to the critical care unit with severe acute pancreatitis (inflammation of the pancreas (large gland behind the stomach-helps to digest food) complicated by infected pancreatic/peripancreatic necrosis (death of most or all of the cells in an organ), intra-abdominal sepsis (life-threatening complication), and respiratory failure ... Impression/Recommendations: ... I [medical doctor (MD) 3] spoke with the patient, his sister [name], and his critical care team [name of MD 4 and 5]. We discussed moving forward ...” operative and non-operative alternatives and proceeding with open exploratory laparotomy (surgery to open the belly area to find the cause of the problem) “ ... I [MD 3] explained why I strongly recommend operative intervention now over all non-operative options ...” Risk and benefits were discussed Pt 25 understood conversation requested his sister be his decision maker and sign consents for him as long as he is not able to sign for himself. During a concurrent interview and record review on 4/25/24, at 10 a.m., with Intensive Care Unit (ICU) RN 6 and the Manager of ICU (MICU), Pt 25’s electronic health records (EHR) for his admission starting 2/26/24 was reviewed. RN 6 stated she was the charge nurse who took care of Pt 25 on 3/24/24. RN 6 stated it is the nurse responsibility to make sure the consent form is done; “We ensure there is a two RN verification over the phone if consent has not been signed yet.” RN 6 stated after reviewing Pt 25’s “Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments,” dated 3/24/24 for procedure Thoracentesis, that this consent was done prior to her receiving the patient and would have been done in Interventional Radiology. RN 6 stated this consent was missing the date, time, relationship of the person signing, witness signatures, and physician signature. RN 6 stated staff in each department are responsible to make sure consents are signed and the nurse and IR (interventional radiologist) should have caught that this information was missing. The MICU stated the expectation is that the consent would be filled out and dated appropriately and it is that departments responsibility to make sure the consent is done. During a concurrent interview and record review on 4/26/24, at 8:56 a.m., with Operating RN 7 Circulator and the Manager of the Operating Room (MOR), Pt 25’s “Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments,” dated 3/25/24 for procedure 1. Exploratory Laparotomy 2. Pancreas necrosectomy 3. Possible temporary closure. RN 7 stated she and the anesthesiologist went to Pt 25’s ICU room and reviewed the consent with Pt 25’s sister and wife on 3/25/24 and the sister signed the consent for the anesthesiologist RN 7 stated then the nephologist came in and asked if they had any questions and had the sister of Pt 25 sign the consent. The MOR stated the consent we are currently reviewing is not the correct consent used for Pt 25’s surgery. The MOR stated this consent is missing the name of the surgeon, Pt 25’s sisters’ signature, date, time, witnesses, and is singed by Pt 25’s attending physician the day before on the 24 th. The MOR stated he reached out to medical records, checked Pt 25’s physical chart and searched for the consent for this surgery and was not able to locate it. The MOR stated he reached out to Pt 25’s sister and confirmed that consent was given for this surgery on 3/25/24 and she had confirmed. The MOR stated the expectation that if signatures are missing on the surgical consent, then his staff would reach out to the family to get consent and if it is over the phone have two witnesses sign that they heard the consent. During an interview on 4/26/24, at 9:17 a.m., with Pt 25’s sister, his sister stated she recalls speaking with the physicians over the phone and gave consent for the exploratory laparotomy that was done on 3/25/24 but does not recall singing the consent. She stated she has not been provided a copy of any of the documents she has signed for her brother and would like a copy of them. She stated she does recall signing the anesthesia consent that was in Spanish but once again is not sure she signed the surgical consent. During a review of the hospital’s policy titled, “Informed Consent/Consent Forms,” last reviewed date 8/2023, indicated, “PURPOSE: To provide information to the patient regarding their health status. Diagnosis, prognosis, and appropriate care. Treatment and services options allowing the patient to make an informed choice, as well as to provide guidelines for completing and witnessing consent forms. Outcome.: Informed consent is obtained after a competent patient. Or person legally authorized to make health care decisions on the patient’s behalf is given sufficient information by the treating physician to make an informed choice, understands the information, and voluntarily agrees to be treated consent. Or not to be treated refusal, thus protecting the patient’s fundamental right to autonomy ... Policy: One. Informed consent is an agreement between the patient and physician slash provider and will be recorded in writing and witnessed. A. All required consent and or releases of responsibility forms will be signed by the patient or responsible party. B. Consent forms will be witnessed by hospital staff within the scope of their practice (e.g., nurse or technologist. Or physicians. Or physician and office staff). C. Prior to the procedure, the patient must be able to sign the consent of their own free will outside of the prepped or draped state that prepares them for the procedure. 2. The physician treating the patient will be responsible for obtaining the patient’s informed consent ... 3. The role of the hospital will be limited to obtaining a verification that the patient’s informed consent has been obtained by the physician before the physician is permitted to perform the procedure ... 5. “Authorization for and consent to surgery or special diagnostic procedure/treatments form” will be completed prior to: A. All procedures performed in the operating room requiring the use of moderate to deep sedation. C. Any minor surgery involving an entry into the body, either through an incision or through a natural body opening. D. Other procedures requiring informed consent. See Appendix A ... General Information: 1. Give the patient or responsible person a duplicate copy of the signed consent form. 2. If the patient/responsible party cannot write, an “X” is a legal signature and is made by the patient’s responsible party beneath the patient’s full name. Such notation must be witnessed and signed by two members of the hospital staff ... 4. If a patient is unable. To sign the consent, the responsible party may give cassette by telephone provided 2 hospital employees (e. g. RN, technologist). Whose signatures are on the consent form. Listen to the phone consent. Verify that the patient has a durable power of attorney. A. Names of responsible party date and time must be fully documented ... 7. The consent form is scanned and is placed in the patient’s chart and becomes a permanent part of the medical record. Consent forms ... Authorization for and consent to surgery or special diagnostic procedure/treatments: 1. List the exact procedure as stated by the physicians written order. A. If there is more than one procedure, list all procedures to be carried out at the same time, on the same consent. B. Only hospital approved abbreviations may be used. 2. List the first and last name(s) of the physician(s) performing the procedure(s). 3. Verify the patient has received the necessary information (Informed Consent). 4. Have the patient read and initial each of the following areas if appropriate: A. Pathology (patient initials: select #1 or #2) ... 6. Verify the signature of the Patient scheduled for the procedure and sign the consent as a witness. 7. Date and time the consent. 8. Give the patient a copy of the consent. 9. Position and Verification of Informed Consent A period after obtaining consent, the treating physician documents the informed consent was given to the patient. This is done by completing the “Physician verification of informed consent” section on Page 3 of the consent form or documenting in EHR ...””

“POLICIES FOR LABORATORY SERVICES CFR(s): 482.27(a)(4) The medical staff and a pathologist must determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examinations. This Standard is not met as evidenced by: 42125 Based on interview and record review the medical staff failed to refer infant remains to the pathologist (a physician who exams tissues and determine abnormal tissue, injury and/or cause of death) for examination of fetal and/or infant remains in accordance with hospital policy and procedure This failure prevented determination of injury, infection and/ or the cause of infant death of 5 of 5 infants, In1, IN2, In3, In4 and In5 by a qualified pathologist. Findings: During an interview and concurrent record review on 4/24/2024 at 11:30 a.m. with (Obstetrician (Medical Doctor and surgeon- MD2) who provides medical care to pregnant mothers and unborn infants), accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), the Patient 1’s (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed MD2 stated she “understands hospital policies ...been at the hospital for twenty years”. MD2 acknowledged she was the medical provider for Pt1 during her stay in the emergency obstetric department (OBED) and the labor and delivery (L&D) unit. MD2 stated that she did not evaluate Pt1 in the OBED, and the Pt1’s “first time” evaluation was 39 minutes after arrival to L&D. MD2 indicated she did not review the fetal heart tones or laboratory values of Pt1. During an interview and concurrent record review on 4/24/2024 at 11:30 a.m., MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise and require emergency intervention to ensure the life and safety of the fetus and mother. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 indicated if a fetus expels meconium (fetal stool), it is abnormal and a sign of fetal distress. During an interview and concurrent record review on 4/24/2024 at 11:30 a.m., Review of the patient’s chart, indicated Pt1 had a “high” white count (WBC, a sign of an infection) of 13.7 (normal 5.5-11) on 3/14/2024 at 5:28 p.m. and 18.2 on 3/15/2024 at 2:16 a.m. Review of Pt1’s delivery notes at 11:33 p.m., indicated MD2 recorded the delivery of the fetus. The record indicated there was a “tight nuchal cord noted around the baby’s neck that could not be reduced ...large 6-inch clot noted in [umbilical] cord at the fetal insertion ...[placenta] membranes meconium stained ... cord and placenta discarded ... infant and patient in delivery room in good and stable condition”. MD2 stated on delivery of the infant and placenta, the infant had a “tight nuchal cord” around the neck and the placenta had an “abnormal large clot”. MD2 stated the placenta, blood clot and meconium were “abnormal”. MD2 stated infant death “could have been from a nuchal cord, but not sure”. MD2 stated she “discarded the placenta and cord” of Pt1’s fetal (Infant, In1) remains. During an interview and concurrent record review on 4/24/2024 at 11:30 a.m., MD2 stated she spoke with the farther ‘only one time” when she informed the mother and father and “explained infant died”. MD2 stated she “did not know the father’s primary language” or speak with the mother regarding autopsy (examination of body remains by a pathologist) of the fetal remains of In1. “[Hospital] Authority for Release of Body” indicated that the “body [infant] released to funeral home” on 3/20/2024. The form titled “Certificate of Vital Records, Certificate of Fetal Death State of California”, dated 4/8/2024 indicated the space for the coroners’ signature and dates were blank. The chart indicated the In1 remains (fetus, placenta and umbilical cord) were not referred to the corners (pathologist, known as a medical examiner) for an autopsy by the MD2 in accordance with hospital policy. There is no documented evidence that the MD discussed with the parents the policy requiring referral to the coroner, autopsy and pathology examination of fetal remains. MD2 indicated she “understood the policies” and requirements regarding fetal demise autopsy and pathology when fetal demise occurs. During an interview with concurrent record review on 4/25/2024 at 9:00 a.m., with Medical Doctor, Emergency Department Director (MD3) accompanied by CMO and DMS, the hospital policies were reviewed and discussed, but MD 3 could not read the records due to technology. MD3 stated the coroner is notified of all deaths that occur in the ED and the “autopsy is decided by the coroner”. During an interview and concurrent record review on 4/24/2024 at 4:45 p.m. with Medical Doctor, Obstetrician and Department Director (MD1), accompanied by CMO) and MRA, the Patient 1’s medical record provided by the hospital and hospital policies were discussed and reviewed. MD1 stated he was the director of the Ob-Gyn department. MD1 acknowledged according to OB gyn policies the OB-GYN department include pediatrics, NICU, and neonatology. The hospital provided a list titled “Expired Death Patient Log”, and documentation of four neonatal deaths (In2, In3, In4 and In5) that occurred at the hospital for the prior 6 months. MD1 stated he was not aware of four of the six deaths in that occurred in the past 6 months. MD1 stated he was aware of a neonatal death due to sepsis, because he “cared for the infant” and Pt1’s infant, In1, but neither of these two were on the log. MD1 indicated that except for two patients he was aware of, he did not know the events surrounding the deaths or why autopsies were not completed. MD1 acknowledged the Ob-Gyn department did not track the events causes of fetal and infant deaths. There was no documented evidence by the physician why the infants or fetuses did not have autopsies. MD1 indicated he was not aware of the hospital policy titled “[Hospital] Patient Care Policy & Procedure, Postmortem Policies, Index No. A-35”. MD1 stated “maybe the policy and laws are wrong” MD1 stated all the placentas and cords of fetal or newborn demise should go to pathology. MD1 stated Pt1’s placenta and cord should not have been “discarded” by MD2 During record review of hospital policy titled “Bylaws of the Medical staff for [Hospital]”, effective 1/27/20212, amendment effective 7/27/20218 stated, “Medical Staff ’ or “Staff ’ means those physicians, dentists, and podiatrists who are Members of the Medical Staff ... BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP providing patients with the quality of care meeting the professional standards of the Medical Staff ... abiding by these Bylaws, the Medical Staff Rules and Regulations, the departmental Rules and Regulations, and the Policies and Procedures of the Medical Staff ... complying with all Federal and State statutes ... Section 6. Deceased Patients ... When a patient expires, the attending physician or any physician Member of the Medical Staff, or a nursing supervisor or competent designee if no physician is readily available will pronounce the patient dead and record this by a written note in the patient’s chart ... Medical Staff Members are encouraged to seek permission and document that effort for autopsy examination on all patients ... Special effort should be made to secure permission for autopsy in many of the following circumstances: 1. When death is not an anticipated outcome; 2. When the cause of death is not known; 3. In situations where autopsy may help allay concerns of the family; 4. When death occurs following a surgical procedure or invasive diagnostic procedure done during the same hospitalization; 5. When death occurs in patients who are participants in formal clinical trials; and 6. All obstetrical and neonatal deaths. During record review of hospital policy titled “[Hospital] Patient Care Policy & Procedure, Postmortem Policies, Index No. A-35”, effective 2/1987, last reviewed 1/2021, stated if “yes to any of the below, you must report the death to the coroner ...All children, including neonates [new born] ... Fetal deaths greater than twenty weeks or greater than four-hundred grams [measure of weight] ... Deaths resulting from known or suspected reportable contagious disease and constituting a public hazard ... Any unnatural cause of death ... Regulatory references ... Title 22 California Code of Regulations ... Government code 27491 [It shall be the duty of the coroner to inquire into and determine the circumstances, manner, and cause of all violent, sudden, or unusual deaths. The coroner shall have discretion to determine the extent of inquiry to be made into any death occurring under natural circumstances] ... Title 17 2500 [Reporting to the local health authority, diseases, and conditions] ... Title 22 [Regulations that apply to Acute care hospitals]”. During record review of hospital policy titled “[Hospital] Patient Care Policy & Procedure, Specimens/Tissue: Care and Handling, Index No. J-1”, effective 1/1986, last reviewed 4/2023, stated “Properly labeled and prepared specimens are delivered to the Laboratory for pathological, microbiological, or chemical examination/analysis ....All specimens removed from a patient will be properly labeled ...Examination by a pathologist .... Product of Conception (POC)/Fetal Newborn Death ... Placenta, requiring genetic studies or cultures ...” California Code of Regulations, Title 22, 70243. Clinical Laboratory Service General Requirements stated “Tissue specimens shall be examined by a physician who is certified or eligible for certification in anatomical and/or clinical pathology by the American Board of Pathology or possesses qualifications which are equivalent to those required for certification ... A record of his findings shall become a part of the patient’s medical record”.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 42125 Based on interview and record review, the hospital failed to ensure Obstetricians (OB physician and surgeon who provides medical care to pregnant mothers and unborn infants) provided standard medical care and followed hospital policies and procedures for the deliverance of safe medical care to pregnant mothers. The failure of 2 of 2 OB surgeons ((Medical Doctor, OB Department Director (MD1) and Medical Doctor, OB (MD2)), to provide timely appropriate medical care and take responsibility for the emergent care of 1 of 1 pregnant mother, (Pt1), jeopardized the safety and well-being of Pt1 and her fetus, and contributed Pt1’s harm and fetal [unborn baby] demise . Findings: Record review of Pt1’s medical care from 3/14/2024 4:38 p.m. to 3/15/2024 10:35 a.m. indicate the following: The chart indicate Pt1 spent 85 minutes in the obstetric emergency department (OBED) plus 33 minutes in L&D before being evaluated by a physician for a medical emergency. On 3/14/2024 at 4:38 p.m., the chart indicated Pt1 arrived at the OBED in “Labor [signs indicating ready to give birth]” and was placed in a room. At 4:45 p.m., the chart indicated a RN (nurse) placed orders for medications, intravenous (I.V.- given via a vein) fluids and monitors, and provided a diagnosis and started to carry out her orders for Pt1. There was no documented evidence, an OBED nurse spoke with a physician. There was no documented evidence a medical screening examination (MSE) for Pt1 and her fetus’ by a physician occurred for an emergency medical condition (EMC). At 5:00 p.m., the nurses documented, Pt1 was placed on a fetal heart monitor for (FHT- measures character, pattern and rate of a fetus’ heartbeat. A normal heartbeat fluctuates between110 to 160 that increase and decrease with sleep, activity and contractions and signals fetal well-being). FHT were measured at 140 beats per minute without the normal heart rate fluctuations (a signal of fetal harm and distress). There was no documented evidence a MSE examination or stabilization an EMC was provided by a physician. At 5:05 p.m., chart indicated verbal orders were “authorized” by MD1 and indicated that the OB physician was to be notified for meconium (fetal stool), fetal heart rate abnormalities per policy. There was no documented evidence MD1 spoke with a nurse or examined the Pt1. At 5:09 p.m., chart indicated MD2 ordered I.V. fluids with instructions: “May increase to 500mL bolus [large volume of I.V. fluid given rapidly] for abnormal fetal heart rate patterns”. There was no documented evidence MD2 spoke with a nurse or examined the Pt1. At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and “therapeutic touch”. At 5:28 p.m., the nurses documented Pt1’s complaints of pain “7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation. At 5:28 p.m., the chart indicated Pt1 had a “high” white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11). At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1. At 5:41 p.m., the chart indicated MD2 signed Pt1’s orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1. At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1. At 5:56 p.m., the nurses documented Pt1’s complaints of “cramping”, “worsening” and pain “7/10”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician examined the Pt1. At 6:02 p.m. the nurses documented fetal heart rate 145 bpm with continued variable deceleration without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence of FHT monitoring strips from 5:42 p.m. onward. There was no documented evidence an OBED nurse spoke with an OB physician. There was no documented evidence an OB physician provided a MSE or stabilization for an EMC prior to Pt1 leaving the OBED. At 6:04 p.m., the chart indicated Pt1 was admitted to Labor and Delivery (L&D) floor and transferred from the OBED. There was no documented evidence Pt1 received a medical exam or medical stabilization by an OB physician on arrival to L&D. At 6:05 p.m., there was no documented evidence of FHT. The chart indicated that a labor epidural (when a women is ready to deliver an infant a doctor can place a catheter in the back that infuses medication to decrease labor pain) was requested by nursing staff. There was no documented evidence MD2 communicated with spoke with Medical Doctor, Anesthesiologist (MD4, provide specialized care before, during and after surgery, procedures and very ill and emergency patients) and requested the procedure or discussed the status of Pt1 and her fetus. The labor epidural was initiated by MD4. From 6:05 p.m. to 6:38 p.m., the chart indicated the L&D nurses were unable to detect FHT. There was no documented evidence an OBED nurse spoke with an OB physician, or Pt1 received a medical exam or medical stabilization by an OB physician. At 6:23 p.m., MD4 completed the epidural. There was no documented evidence, MD4 interrupted the epidural to determine the status of Pt1 and the fetus. There was no documented evidence MD4 spoke with an OB physician to discuss the status of Pt1 and the fetus. At 6:25 p.m., the nursing exam note indicated, unable to locate FHT, and “no fetal movement”. There was no documented evidence an OB physician was at Pt1’s bedside. At 6:39 p.m., the chart indicated MD2 was called to the bedside. The chart indicated this was the first evaulation of Pt1 by an OB physician. MD2 documented “no fetal heart tones per” and diagnosed “IUFD [intrauterine fetal demise, death of infant before birth]”. At 11:26 p.m., the nurse’s note indicated, “meconium” before the delivery of the infant. At 11:33 p.m., MD2 recorded the delivery of the fetus. The record indicated there was a “tight nuchal cord [the umbilical cord connects mother and baby in the womb and supplies blood, oxygen and nutrients to the fetus that gets tangled causing a decrease or absent blood flow] ...noted around the baby’s neck that could not be reduced ...large 6 inch clot noted in [umbilical] cord at the fetal insertion ...[placenta] membranes meconium stained ... cord and placenta [organ in the womb that hold fluid and the fetus] discarded ... infant and patient in delivery room in good and stable condition”. There was no documented evidence MD2 sent fetal remains for examination by a pathologist (a physician who exams tissues and determines abnormal tissue, injury and/or cause of death). On 3/15/2024 at 2:16 a.m., review of the patient’s chart, indicated Pt1 had a “high” white count of 18.2, increased from 13.7 (normal 5.5-11) a few hours earlier. On 3/15/2024 at 10:35 a.m. the chart indicated MD1 evaluated Pt1 for the first time. During an interview and concurrent record review on 4/24/2024 at 11:30 with MD2, accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), Patient 1’s (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. MD2 stated that on 3/14/2024 on call she was on call to see patients in the OBED, and was “available” to attend to OB emergencies. MD2 acknowledged she was responsible physician for the OB emergency services, MSE and stabilization of OB patients, and not the nurses. MD2 stated she “understands hospital policies ...been at the hospital for twenty years” and EMTALA (Emergency Medical Treatment and Labor Act). MD2 indicated she understood responsibilities of emergency care of pregnant patients. MD2 indicated that the emergency department for obstetrics (OBED) was a unit that evaluated emergency pregnant patients, determined their acuity, diagnosed medical issues, made a plan of care, managed and stabilized them. MD2 stated the patient will be “seen by the nurses [RNs]”. MD2 stated “nurses are “qualified” to complete medical screening exams (MSE) and provide stabilizing medical treatment and if the “RN needs direction, it is given over the phone”. MD2 stated if she “can’t see the patient ... over the phone ...give directions” to the nurse. MD2 stated the physician “doesn’t need to see the patient”, and this has been the “standard” for years at the hospital. MD2 stated, without a physician evaluation of a pregnant patient, nurses are allowed to place “verbal orders” for medications, monitors, intravenous fluids, treatments and provide an admitting diagnosis for a patient in the computer without a physician evaluation or communication. MD2 stated that she “signs 100’s of orders” from the nurses that “pop-up” in her computer “inbox” and one of her “chores” is to e-sign (electronically sign) and approve orders from nurses. MD2 indicated she does not evaluate patients that she signs verbal orders for, nor determine who the orders are for or why they were ordered by the nurse. MD2 stated she “doesn’t call the nurses when verbal orders are placed by the nurse ... I sign the orders” for nurses. Pt1’s timeline of events was reviewed with MD2. MD2 stated discussing Pt1’s care was a “loaded question”. MD2 stated that on 3/14/2024 on call she was on call to see patients in the OBED. MD2 acknowledged she was responsible physician for the OB emergency services, MSE and stabilization of OB patients, and not the nurses. MD2 stated she was “available” to see Pt1 when she arrived at the emergency department for obstetrics (OBED) at 4:39 p.m. but did not provide a MSE or stabilization for Pt1 and her fetus’ EMC or speak with the OB nurses. At 5:09 p.m., the chart indicated MD2 ordered intravenous fluids, MD2 acknowledged that she did not speak to the nurses or evaluate Pt1. MD2 acknowledged at 5:41 p.m., she signed and agreed with the OBED diagnosis and orders that the nurse had placed in the computer as “verbal orders”. MD2 acknowledges she did not call the nurse about the PT1’s status and emergency medical condition, nor ask the nurses about the orders placed or admitting diagnosis. MD2 acknowledged she did not evaluate Pt1 or call the and speak to the nurses and ask about Pt1’s EMC, medical status or distress when she placed orders and signed the nurses’ orders. MD2 stated ongoing fetal (unborn baby) heart tones (FHT, character, pattern and rate of a fetus’ heart) are “important to monitor” and reflect the “well-being of the infant”. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise and require emergency intervention to ensure the life and safety of the fetus and mother. MD2 indicated if a fetus expels meconium (fetal stool), it is abnormal and a sign of fetal distress. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 indicated OB RNs are “qualified” to interrupt, diagnose and act upon abnormal FHT, but are not physicians. Thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and/or surgeries. The chart indicated for 62 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations and after that, for another 25 minutes, FHT could not be located. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD2. MD2 stated that she “never saw” the FHT monitor strips (recordings of fetal heart tones) during Pt1’s hospital admission. MD2 stated the Pt1’s FHT tracing strips were “not normal” because there was “variable deceleration”, “no reaction” of the baby to contractions or other signals of fetal well-being. MD2 acknowledged the tracings that did not improve and “could signal an emergency” for the fetus and mother. MD2 indicated she did not receive a call from the nurse regarding the abnormal FHTs. MD2 stated OB RNs are “qualified” to interrupt, diagnose and act upon abnormal FHT. Review of the patient’s chart, indicated Pt1 had a “high” white count (WBC, a sign of an infection) of 13.7 (normal 5.5-11) on 3/14/2024 at 5:28 p.m. and 18.2 on 3/15/2024 at 2:16 a.m. There was no documented evidence MD2 reviewed the labs, provided an interruption of the labs or initiated care to Pt1. MD2 acknowledged Pt1 spent 85 minutes in the OBED plus 33 minutes in L&D before being evaluated by a physician for a medical emergency. MD2 indicated that she did not provide medical oversight or direction to the OBED and L&D nurses who provided the ongoing evalautions and orders for Pt1’s EMC for the first 118 minutes Pt1 was in the facility. MD2 stated she was called because the nurses “could not find FHTs” and evaluated the Pt1 for the “first time” at 6:39 p.m. Pt1’s delivery note was reviewed with MD2. MD2 stated the delivery of the infant and placenta was at 11:33 p.m. The infant had a “tight nuchal cord” around the neck and the placenta had an “abnormal large clot”. MD2 stated the placenta, umbilical cord, blood clot and meconium were “abnormal”. MD2 stated infant death “could have been from a nuchal cord, but not sure”. MD2 stated she “discarded the placenta and cord”. MD2 indicated she “understood the policies” and requirements regarding fetal demise autopsy and pathology when fetal demise occurs. MD2 stated she spoke with the farther ‘only one time” when she informed the mother and father and “explained infant died”. MD stated “she “did not know the father’s primary language”. There is no documented evidence that the MD discussed with the parents the policy requiring referral to the coroner, autopsy and pathology examination of fetal remains During a interview and concurrent record review on 4/24/2024 at 4:45 p.m. with MD1, accompanied by CMO and MRA, Patient 1’s medical record provided by the hospital and hospital policies were discussed and reviewed. MD1 stated he was the Director of the OB department. MD1 stated indicated he understood EMTALA requirements and OB policies. MD1 stated the “concerns” on the OB floors are related to “problems caused by [hospital] management”. MD1 indicated that management “hired nurses” to work on OB floor and have “zero management oversite” of the care they provided. The nurses “didn’t know how to put on monitors and didn’t know what was going on” with pregnant mothers and fetal status”. MD1 indicated that he was not in agreement with hospital policies regarding the response time requirements to provide patients with an evaluation and time requirements to address maternal and/or fetal comprise and distress. MD1 stated the OBED physician will evaluate patients who arrive at the emergency department, but the evaluation time “expectation is a tricky question ...and depends”. MD1 explained the “normal process” in the OBED. MD1 stated OB RNs are “QMP [non-physician qualified medical provide; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries. ]” and complete a medical screening exam (MSE), stabilizations and ongoing evalautions for OB and L&D patients. the nurses will “triage [determine level of acuity]” and determine if there is an “emergency”. MD1 stated the “standard for years” at the hospital has allowed the nurses to use their “judgment” to diagnosis, order medications and treatments, and admit to patients in order to “expedite” medical care that may otherwise be “delayed”. After the nurse has provided a MSE, without physician evaluation or communication, the nurses will place orders, as “verbal orders”, for medications, monitors, intravenous fluids, treatments, diagnosis and admit patients The orders written by the nurses are sent to the physicians “in box” electronically and the physician will sign them up to 2 days later. MD1 stated he receives “100’s of orders [written by nurses] and do not check who they are from ... it is difficult to verify who and what the orders are for ...just sign-off” without review. At some time, the nurses will “talk with the physician” about the patient’s status. It’s “standard procedure” at the hospital. MD1 stated continuous FHT monitors “make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay”. MD1 stated he does not agree with the time recommended to intervene for abnormal FHT tracings that last greater than 20 minutes. The hospital policy titled Patient Care Policy and Procedure for: Women’s and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21” was reviewed with MD1.It indicated management of possible FHR patterns: Category I (CAT1): Routine management. Normal FHR baseline between 110 and 160 bpm (heart beat per minute) with variability (an increase or decrease of 6 to 25 bpm of FHR with sleep, activity and mother’s contractions MD1 stated CAT1 “reassures” fetal well-being. Category II (CAT2): Absent FHR acceleration (normal increase is 6 - 25 bpm from bassline with a maximum HR of 160 bpm) and/or absent or minimal FHR variability (amplitude (height) range undetectable and less or equal to 5 bpm variability. Tachycardia (fast heart rate greater than 160). “ If FHR do not improve consider delivery”. MD1 acknowledged that the CAT 2 tracing could change to CAT 3 emergency tracings. Category III (CAT3): FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing “do not improve, consider prompt delivery”. MD1 stated he was not in agreement with the time limitations. The chart indicated for 62 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations and after for another 25 minutes FHT could not be located. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD1. MD1 stated the first variable deceleration was at 5:36 p.m., and FHT monitoring records were not available after 5:48 p.m. According to nursing documentation, variable decelerations were still present at 6:02 p.m. After 6:05 p.m., MD1 indicated after arrival on the L&D floor, the couple of minutes of FHT tracing strips were not informative and may have been the “mother’s heart rate”. MD1 stated after 5:48 p.m., “something happened” to the baby” and fetal well-being “could not be determined”. MD1 acknowledged that FHT tracing were abnormal, may have changed to CAT3 and required emergency intervention. MD1 stated he does not agree with policy that a physician should evaluate and intervene if abnormal FHT tracings last greater than 20 minutes. MD1 indicated OB nurses are qualified to interrupt, diagnose and respond to abnormal FHT. MD1 stated if the nursing staff were “not worried” about FHT than “nothing is done”. MD1 acknowledged MD2 was on call for the OBED and L&D emergencies on 3/14/2024 and was responsible for Pt1’s care from 3/14/204 at 4:38 p.m. until the next morning. MD1 indicated that he was the primary OB provider for Pt1 on 3/14/2024 from 4:46 p.m. to 3/15/2024 3:10 p.m., because he had been her physician throughout pregnancy. The records indicated MD1 “authorized” nurse to place orders under his name for Pt1 on 3/14/2024 as early as 5:05 p.m. On 3/14/2024, MD1 stated he did not evaluate Pt1 or discuss her status with the nurses. MD1 stated he only evaluated Pt1 on 3/15/2024. MD1 indicated that OB emergency medical services and ongoing evaluations and stabilization of Pt1 and her fetus was provided nurses, and not physicians from 3:38 p.m. to 6:39 p.m. MD1 stated all the placentas and cords of fetal or newborn demise should go to pathology. MD1 stated Pt1’s placenta and cord should not have been “discarded” by MD2. MD1 stated “during root cause analysis (RCA- a process to uncover causes of problems) and interview with the nurses”, they reported “heard FHT”, but there were no FHT strips. MD1 indicated hearing noise does not determine fetal well-being, “it could have been the mother’s” heartbeat. MD1 stated Pt1 was removed from the monitors at 5:48 p.m. and it appeared “the fetus was alive ... but not properly monitored in the OBED after 5:48 p.m. and not on L&D”. The chart indicate Pt1 spent 85 minutes in the OBED plus another 33 minutes in L&D before being evaluated by the OBED on call physician, MD2, for a medical emergency. MD1 acknowledged MD2 did not provide Pt1 care in the OBED, did not evaluate Pt 1’s EMC, provide a MSE or stabilizing medical care to Pt1 and her fetus. MD1 stated it took “longer than expected” for Pt1 to be evaluated by MD2. MD1 stated, even if Pt1 and her fetus had a timely MSE, evaluation and stabilization it “would not have made a difference in the outcome ...fetal demise would have occurred”. It was “unfortunate”. MD1 stated the “physicians and nurses do a great job ...experienced ... the hospital is not unsafe”. During a interview and concurrent record review on 4/25/2024 at 9:00 a.m. with Medical Doctor, Emergency Department Director (MD3) accompanied CMO and DMS, hospital policies were reviewed and discussed, but MD 3 could not see the records due to technology. MD3 stated he was the medical director for the hospital emergency department (ED). MD3 stated indicated that he understood EMTALA requirements and hospital policies. MD3 stated there should “always” be a physician in the ED, and there is “never” a case when there is not. MD3 indicated patients who arrive at the ED are screened for an EMC, provided a MSE and stabilizing medical treatment. MD3 stated the patient is the responsibility of the physician and medical care is provided “as soon as you can”. MD3 stated an EMC, MSE and stabilization of patient is “not done the over the phone” by a physician and “nobody [patient] leaves the department without a face-to-face evaluation”. MD3 stated a pregnant woman in labor who arrive in the OBED or ED, EMTALA requirements still apply. MD3 indicated OB patients can be seen in the main ED and are provided a MSE and stabilization. If the complaint labor or pregnancy related, after triage, the patient is “escorted” by ED staff to the OBED. On the other hand, a pregnant women go directly to the OBED for an EMC, receive an MSE and stabilizing treatment by an OB physician and it’s “not done by phone”. During record review of hospital policy titled “Bylaws of the Medical staff for [Hospital]”, effective 1/27/20212, amendment effective 7/27/20218 indicated that Basic responsibilities of the medical staff included “providing patients with the quality of care meeting the professional standards of the Medical Staff ... abiding by these Bylaws, the Medical Staff Rules and Regulations, the departmental Rules and Regulations, and the Policies and Procedures of the Medical Staff ... complying with all Federal and State statutes ... A Member of the Medical Staff shall be responsible for the medical care and treatment of the patients for whom he or she is the admitting or primary physician ... Each Medical Staff Member must assure timely, adequate, professional care for his patients in the Hospital ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders ... Emergency Services The Medical Staff shall adopt a method of providing medical coverage in the Department of Emergency Medicine ... Physician Members of the Department of Emergency Medicine shall be under the direction of the director, who shall be responsible for the professional activities of Members of the department and the quality of patient care rendered by such Members ... will be bound by the provisions of Paragraph 1317 of the Health & Safety Code, State of California [CA EMTALA Care Law] ... Medical Records ...completing accurate and complete medical records including electronic records ... The updated examination of the patient, including any changes in the patient’s condition, must be completed and documented by a physician ...Pertinent progress notes shall be recorded at the time of observation sufficient to permit continuity of care and transferability”. During record review of the hospital policy titled, Department of OB-GYN [obstetrics (OB)- care of pregnanat women & Gynecology (GYN) women’s reproductive system] /Perinatology, [care of pregnant mothers-woman’s heath/care of fetus, unborn baby], Rules and Regulations”, effective 5/2012, last reviewed 8/2023, stated that “EMTALA requirements related to obstetric care should be as follows: 1. A medical screening examination (MSE) must be performed by an appropriately privileged physician to determine whether the patient has an emergency medical condition, 2. If an emergency medical condition exists, patient must be stabilized and transferred to the labor unit or appropriate acute care hospital department ...labor and delivery nurse is qualified by virtue of his/her training to perform the medical screening exam to determine the presence of labor”. During record review of hospital policy titled, “[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5”, effective June 2014, last reviewed 4/2020, stated that “assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay ... Patients in labor will be transferred to the Labor and Delivery unit after an appropriate medical screening examination and stabilization in accordance with EMTALA regulations”. During record review of hospital policy titled “[Hospital] OB Emergency Services Standardized Procedure, Standardized Procedure: OB Medical Screening Examination index No. G-3”, effective June 2014, last reviewed 1/2022, stated that “ Supervision: The OB ED physician or patient’s primary OB physician will provide supervision... A pregnant individual having contractions is considered to have an emergency medical condition ... ‘Emergency medical condition’ means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the pregnant woman and/or her unborn child in serious jeopardy ... Diagnosis: Physician is to give a diagnosis on all patients receiving a MSE in OBED”. During record review of Patient Care Policy and Procedure for: Women’s and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21”, effective 3/2020, last reviewed 8/2023, stated that “All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing”. The tables in the policy indicated management of possible FHR patterns: Category I: Routine management. Normal FHR baseline between 110 and 160 bpm with variability (10 to 25 bpm increase or decrease of FHR with sleep, activity and mother’s contractions). Also considered “reassure” fetal well-being ... Category II: Absent FHR acceleration (normal increase is 10 - 25 bpm from bassline and maximum HR of less than 160 bpm) and/or absent/minimal FHR variability (Amplitude range undetectable and ? (less or equal to) 5 bpm (heart beat per minute] variability. Tachycardia (fast heart rate) Baseline rate greater than160 bpm. If FHR do not improve consider delivery ... Category III FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing do not improve, consider prompt delivery”. During review of California Code of Regulations, Title 22, 70243. Clinical Laboratory Service General Requirements stated “Tissue specimens shall be examined by a physician who is certified or eligible for certification in anatomical and/or clinical pathology by the American Board of Pathology or possesses qualifications which are equivalent to those required for certification ... A record of his findings shall become a part of the patient’s medical record”. During record review of hospital policy titled “[Hospital] Patient Care Policy & Procedure, Specimens/Tissue: Care and Handling, Index No. J-1”, effective 1/1986, last reviewed 4/2023, stated “Properly labeled and prepared specimens are delivered to the Laboratory for pathological, microbiological, or chemical examination/analysis ....All specimens removed from a patient will be properly labeled ...Examination by a pathologist .... Product of Conception (POC)/Fetal Newborn Death ... Placenta, requiring genetic studies or cultures”. During record review of hospital policy titled “[Hospital] Patient Care Policy & Procedure, Postmortem Policies, Index No. A-35”, effective 2/1987, last reviewed 1/2021, stated if “yes to any of the below, you must report the death to the coroner ...All children, including neonates [new born] ... Fetal deaths greater than twenty weeks or greater than four-hundred grams [measure of weight] ... Deaths resulting from known or suspected reportable contagious disease and constituting a public hazard ... Any unnatural cause of death ... Regulatory references ... Title 22 California Code of Regulations ... Government code 27491 [It shall be the duty of the coroner to inquire into and determine the circumstances, manner, and cause of all violent, sudden, or unusual deaths. The coroner shall have discretion to determine the extent of inquiry to be made into any death occurring under natural circumstances] ... Title 17 2500 [Reporting to the local health authority, diseases and conditions] ... Title 22 [Regulations that apply to Acute care hospitals]”.”

“ORGANIZATION OF ANESTHESIA SERVICES CFR(s): 482.52(a), (c) The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by: (1) A qualified anesthesiologist; (2) A doctor of medicine or osteopathy (other than an anesthesiologist); (3) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; (4) A certified registered nurse anesthetist (CRNA), as defined in §410.69(b) of this chapter, who, unless exempted in accordance with paragraph (c) of this section, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or (5) An anesthesiologist’s assistant, as defined in Sec. 410.69(b) of this chapter, who is under the supervision of an anesthesiologist who is immediately available if needed. State Exemption (1) A hospital may be exempted from the requirement for MD/DO supervision of CRNAs as described in paragraph (a)(4) of this section, if the State in which the hospital is located submits a letter to CMS signed by the Governor, following consultation with the State’s Boards of Medicine and Nursing, requesting exemption from MD/DO supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State’s citizens to opt-out of the current MD/DO supervision requirement, and that the opt-out is consistent with State law. (2) The request for exemption and recognition of State laws, and the withdrawal of the request may be submitted at any time, and are effective upon submission. This Standard is not met as evidenced by: 42125 Based on interview and record review, the hospital failed to follow Medical Staff Bylaws, Rules and Regulations and California state law and ensure anesthesia services (specialized care before for surgery, pain management, critical care and emergencies), were appropriate to a Certified Registered Nurse Anesthetist’s (CRNAs- a nurse trained to provide anesthesia (specialized care before for surgery, pain management, critical care and emergencies) scope of the practice and were appointed to the Medical Staff by the Governing Body (GB- a committee that leads a health care organization’s compliance and quality oversight efforts), as “independent practitioners” and the same as anesthesiologist (physician specialist who provides anesthesia medical care for surgery, pain management, critical care and emergencies who has full prescriptive, diagnostic and therapeutic authority). The failure to have physician’s orders, discretion and oversight of the anesthesia services including for on-call, high risk invasive procedures and emergency services, provided by 3 of 3 CRNAs had the potential of endangering any patients who received “independent” anesthesia care from a non-physician (not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries). Findings: During an interview and concurrent record review on 4/25/2024 at 2:09 p.m., with the Medical staff team which included Chief Medical Officer and Obstetrician (CMO), Director of Medical Staff Affairs (DMS), Director of Medical Staff Affairs (DMS), Registered Nurse, Quality, Scribe (RNQ1), and Manager of Regulatory and Accreditation (MRA), hospital polices and the files of three CRNAs, (CRNA1, CRNA2, and CRNA3) were requested to be available for review by CDPH. To start the record review, CRNA polices, and forms were discussed. The hospital policy titled, “Allied Health Professional [AHP] Policy/Procedure Manual”, indicated “Allied Health Professional or AHP means an individual, other than a licensed physician which included CRNAs ... CRNAs are privileged to perform tasks and functions which fall within the usual and customary scope of nursing practices ... under the supervision or the direction of a Medical Staff member possessing privileges to provide such care in the Hospital ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders”. DSM indicated the “CRNA Privilege Form describes the CRNAs’ scope practice at the facility and if privileges are approved, CRNAs have “authority to practice independently”,” and can provide to any patient medical care at the facility like an anesthesiologist. The CMO and DSM stated CRNAs are “independent practitioners” and based on “the laws” CRNAs can diagnosis, plus prescribe and order any medication, therapeutics, and treatment for patients without physician orders, oversight or discretion. The CMO and DSM indicated CRNAs have the same scope of practice and independence as an anesthesiologist. During an interview and concurrent record review on 4/25/2024 at 2:09 p.m., A list of CRNAs with anesthesia privileges at the hospital was provided by the DSM. The list indicated Twenty-eight of the 33 CRNAs did not have a “sponsoring physician” recorded. The “Anesthesia Call List Calendar” for dates of September 1, 2023 to April 24, 2024, provided by the hospital, listed CRNAs on call every day to provided medical services to patients for emergencies, surgeries, anesthesia obstetrics (OB- care for pregnant mothers and unborn infant), an airway management (provided medical care to patients who difficulty with breathing) and/or critical care procedures (undefined by facility or privilege form), and there was not a physician named who provided for medical direction, oversight and/or orders. DSM stated the hospital does not require CRNAs to have a “supervising or sponsoring physician”. During an interview and concurrent record review on 4/25/2024 at 2:09 p.m., DSM pointed to the hospital policy titled, “CA association of Nurse Anesthetists (CANA) CRNA scope of Practice Guidelines” and stated “CRNAs are not required to have DEA number [Drug Enforcement Administration license that allows providers to order, procure and prescribe medications]”. DSM stated CRNAs are allowed to order medications under California “AB 15 [Assembly Bill AB No.15, COVID 19 relief: tenancy: Tenant Stabilization Act of 2021]”. DSM stated “according to California law CRNAs provide independent medical care” without a medical license. DSM stated several times the laws and policy gave CRNAs the authority to practice independently, and prescribe and order medications, therapeutics, and treatments. The CMO agreed with DSM but stated that he will check with “legal counsel to make sure doing things right”. During an interview on 4/24/2024 at 2:30 a.m. with Medical Doctor, Anesthesiologist (MD4), accompanied by CMO and DMS, hospital policies were reviewed and discussed. MD4 stated he has been practicing anesthesia since 1990. MD4 stated at the facility, CRNAs provide anesthesia services and are “independent practitioners” and provide medical care to patients without the involvement of a physician. MD4 indicated he does not supervise or provide physician oversight or medical direction for CRNAs, nor write orders for CRNAs to provide medical services. During an interview on 4/25/2024 at 1:00 p.m. with Anesthesiologist (MD5), accompanied by CMO, DMS and Registered Nurse, Quality, Scribe (RNQ2) hospital policies were reviewed and discussed. MD5 state he has been practicing anesthesia for 16 years. MD5 stated at the facility, CRNAs provide anesthesia services and “practice independently”, like “any other physician”. CRNAs provide on-call anesthesia coverage to patients, including obstetrics (OB) and emergencies without the involvement of a physician. MD5 indicated he does provide physician oversight or medical direction to CRNAs, nor write orders for CRNAs to provide medical services, treatments, therapeutics, or medications. During an interview with concurrent record review on 4/24/2024 at 3:30 p.m., with Anesthesiologist, (MD6) provide accompanied by Chief Medical Officer, CMO and DMS, the provider agreements were reviewed and discussed. MD6 stated he is the managing director of the anesthesia agreement with the facility and prior director of the department. MD6 stated he has been an anesthesiologist for over 26 years. MD6 stated the CRNA at the facility work under the current anesthesia agreements with companies that he manages. MD6 stated the structure is a “partnership”. MD6 stated CRNAs are “restricted” from being considered independent contractors, unlike physicians because of California AB 5 (Assembly Bill No. 5, Worker status: employees and independent contractors). MD6 stated at the facility CRNA provided the “full gamut of anesthesia services”. MD6 indicated CRNAs are on call at the hospitals to provide “independent” medical services for emergencies, surgeries, anesthesia obstetrics, an airway management and/or critical care procedures, and there was not an anesthesiologist who provided for medical direction, oversight and/or orders for the CRNA. Even though the contract indicated non-physician personnel and the anesthesia group “shall supervise the activities of such personnel while in the clinical/technical performance of Anesthesia Services and in the presence of an Anesthesiologist”. The hospital has designated that CRNAs are non-physician, Advance Health Provider (AHP), but MD6 stated at the hospital, CRNAs are “independent practitioners”, like physicians and provide the same services. MD6 stated CRNA do not have DEA licenses (DEA- Drug Enforcement Administration allows a physician to prescribe drugs prescribe, order, and procure drugs), but doesn’t understand how CRNAs can order and prescribe medications. MD6 indicated anesthesiologists in the group do not write orders for treatments, medications, or therapeutics for CRNAs, provide oversight or direction, nor under their discretion. During record review of hospital document title, “Copy of AHP Roster”, the documented indicated the following: listed 33 CRNAs who were on medical staff and approved to provide anesthesia services. CRNAs were listed as “AHP” and “Expertise ... Anesthesiology”. Twenty-eight of 33 CRNAs did not have a sponsoring physician recorded. The documents stated, “Sponsor name [of physician], CRNA does not require supervising physician”. Thirty-three of the CRNAs did not have a listed physician of record for oversight, direction, or orders. During record review of hospital document title, “Anesthesia Call List Calendar” for dates of September 1, 2023 to April 24, 2024, listed CRNAs on call every day in order to provided medical services to patients for emergencies, anesthesia obstetrics (OB- care for pregnant mothers and unborn infant), an airway management (provided medical care to patients who difficulty with breathing) and/or critical care procedures (undefined by facility or privileges), without a named physician for medical direction, oversight and/or orders. During record review of hospital titled “Allied Health Professional [AHP] Policy/Procedure Manual”, revised May 2023, stated “Allied Health Professional or AHP means an individual, other than a licensed physician, dentist, or podiatrist, who exercises independent judgment within the areas of his or her professional competence ... who is qualified to render direct or indirect medical, dental, or podiatric care under the supervision or the discretion of a Medical Staff member possessing privileges to provide such care in the hospital ... Advanced Practice Professionals (APP) are: Certified Registered Nurse Anesthetist (a nurse trained to provide anesthesia care under the orders and discretion of a physician), Nurse Practitioner (a nurse trained to provided medical care under standardized procedures, that is, specific directions from a physician), Physician Assistant (a nurse or other person trained to provided medical care under a practice agreement, that is, specific directions from a physician) ... CRNAs are privileged to perform tasks and functions which fall within the usual and customary scope of nursing practices”. During record review of hospital form titled, “CRNA Privilege Form CRNA Scope. Privilege form” for anesthesia practice at the hospital, indicated that CRNAs are “Allied Health Professional or AHP... other than a licensed physician ...Request and interpret results of any indicative diagnostic laboratory test ... Assess and implement appropriate treatment for any problems ... Select pre-medication ...make decisions to withhold certain medications ... implement corrective actions ... Core privileges include Regional Anesthesia [subspecialty of anesthesiology, which may take an additional year of training. They are procedures that can take away all feeling from a specific part of the body using special drugs]. Venous Catheters [high risk procedures that are associated with increased injury and death]”. During record review of California (CA) Business and Professions Code (BPC) 2826, stipulated that a “Nurse anesthetist’ means a person who is a registered nurse licensed by the board who has met standards for certification from the board”. During record review of CA BPC, 2725(b)(2) stipulated that “Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician”. During review of CA BPC 2827 stipulated, the “utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist”. During review of CA BPC 2833.5, stipulated that “the practice of nurse anesthetist does not confer authority to practice medicine or surgery”. During record review of hospital policy titled “Bylaws of the Medical staff for [Hospital]”, effective 1/27/20212, amendment effective 7/27/20218 stated that “Medical Staff ’ or ‘Staff ’ means those physicians, dentists, and podiatrists who are Members of the Medical Staff ... Allied Health Professional or AHP means an individual, other than a licensed physician, dentist, or podiatrist, who exercises independent judgment within the areas of his or her professional competence and the applicable State Practice Act, who is qualified to render direct or indirect medical, dental, or podiatric care under the supervision or the direction of a Medical Staff member possessing privileges to provide such care in the Hospital ...AHPs are not eligible for Medical Staff membership ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders”. During record review of hospital document title, “Copy of AHP Roster”, the documented indicated the following: listed 33 CRNAs who were on medical staff and approved to provide anesthesia services. CRNAs were listed as “AHP” and “Expertise ... Anesthesiology”. Twenty-eight of 33 CRNAs did not have a sponsoring physician recorded. The documents stated, “Sponsor name [of physician], CRNA does not require supervising physician”. Thirty-three of the CRNAs did not have a listed physician of record for oversight, direction, or orders. During record review of hospital document title, “Anesthesia Call List Calendar” for dates of September 1, 2023 to April 24, 2024, listed CRNAs on call every day to provided medical services to patients for emergencies, anesthesia obstetrics (OB, care for pregnant mothers and unborn infant), an airway management (provided medical care to patients who difficulty with breathing) and/or critical care procedures (undefined by facility or privileges), without a named physician for medical direction, oversight and/or orders. During record review of hospital titled “Allied Health Professional [AHP] Policy/Procedure Manual”, revised May 2023, stated “Allied Health Professional or AHP means an individual, other than a licensed physician, dentist, or podiatrist, who exercises independent judgment within the areas of his or her professional competence ... who is qualified to render direct or indirect medical, dental, or podiatric care under the supervision or the direction of a Medical Staff member possessing privileges to provide such care in the hospital ... Advanced Practice Professionals (APP) are: Certified Registered Nurse Anesthetist (a nurse trained to provide anesthesia care under the orders and discretion of a physician), Nurse Practitioner (a nurse trained to provided medical care under standardized procedures, that is, specific directions from a physician), Physician Assistant (a nurse or other person trained to provided medical care under a practice agreement, that is, specific directions from a physician) ... CRNAs are privileged to perform tasks and functions which fall within the usual and customary scope of nursing practices”. During record review of hospital document titled “Professional Services Agreement Amendment Two and Restatement Department of Anesthesia, an agreement between [Hospital] and Anesthesia Group”, indicated the “Group employs or otherwise contracts with physicians and certified Registered Nurse Anesthetists ...Hospital wishes to assure proper and consistent clinical supervision and administration of the Department, appropriate control and standardization of clinical procedures performed in the Department, necessary clinical education and training .... OB Anesthesia Coverage. Group agrees to provide in-house Anesthesia Services for Obstetrics (OB) cases twenty-four hours a day, seven days a week ... Non-physician Personnel ... Group shall supervise the activities of such personnel while in the clinical/technical performance of Anesthesia Services and in the presence of an Anesthesiologist, and Hospital shall be solely responsible for such personnel in all other aspects of their employment”. Group agreed anesthesia services would be provided by CRNAs and/or anesthesiologists who practice independently.”

“PRE-ANESTHESIA EVALUATION CFR(s): 482.52(b)(1) [The policies must ensure that the following are provided for each patient:] A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, performed within 48 hours prior to surgery or a procedure requiring anesthesia services. This Standard is not met as evidenced by: 42125 Based on interview and record review, in accordance with hospital policy, a pre-anesthesia procedure evaluation for one of one pregnant patient, (Pt1), was not completed by the medical doctor, anesthesiologist (MD4- physician who provides specialized care before, during and after surgery, procedures to decrease pain, and emergency care). The failure to determine Pt1’s medical condition and status of the fetus, before initiating a labor epidural (a type of regional anesthesia where a doctor places a catheter tube in the patient’s back and infuses medication to decrease labor pain) missed problems and protentional complications that may have contributed to patient harm and fetal demise. Findings: Record review of Pt1’s medical care on 3/14/2024 from 4:38 p.m. to 6:05 p.m. indicate the following: On 3/14/2024 at 4:38 p.m., the chart indicated Pt1 arrived at the OBED in “Labor [signs indicating ready to give birth]” and was placed in a room. At 4:45 p.m., the chart indicated a RN (nurse) placed orders for medications, intravenous (I.V.- given via a vein) fluids and monitors, and provided a diagnosis and started to carry out her orders for Pt1. There was no documented evidence, an OBED nurse spoke with a physician. There was no documented evidence a medical screening examination (MSE) by a physician occurred for an emergency medical condition (EMC). At 5:00 p.m., the nurses documented, Pt1 was placed on a fetal heart monitor for (FHT- measures character, pattern and rate of a fetus’ heartbeat. A normal heartbeat fluctuates between110 to 160 that increase and decrease with sleep, activity and contractions and signals fetal well-being). FHT were measured at 140 beats per minute without the normal heart rate fluctuations (a signal of fetal harm and distress). There was no documented evidence a MSE examination or stabilization an EMC was provided by a physician. At 5:05 p.m., chart indicated verbal orders were “authorized” by MD1 and indicated that the OB physician was to be notified for meconium (fetal stool), fetal heart rate abnormalities per policy. There was no documented evidence MD1 spoke with a nurse or examined the Pt1. At 5:09 p.m., chart indicated MD2 ordered I.V. fluids with instructions: “May increase to 500mL bolus [large volume of I.V. fluid given rapidly] for abnormal fetal heart rate patterns”. There was no documented evidence MD2 spoke with a nurse or examined the Pt1. At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and “therapeutic touch”. At 5:28 p.m., the nurses documented Pt1’s complaints of pain “7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation. At 5:28 p.m., the chart indicated Pt1 had a “high” white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11). At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1. At 5:41 p.m., the chart indicated MD2 signed Pt1’s orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1. At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1. At 5:56 p.m., the nurses documented Pt1’s complaints of “cramping”, “worsening” and pain “7/10”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician examined the Pt1. At 6:02 p.m. the nurses documented fetal heart rate 145 bpm with continued variable deceleration without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence of FHT monitoring strips from 5:42 p.m. onward. There was no documented evidence an OBED nurse spoke with an OB physician. There was no documented evidence an OB physician provided a MSE or stabilization for an EMC prior to Pt1 leaving the OBED. At 6:04 p.m., the chart indicated Pt1 was admitted to Labor and Delivery (L&D) floor and transferred from the OBED. There was no documented evidence Pt1 received a medical exam or medical stabilization by an OB physician on arrival to L&D. At 6:05 p.m., Prior to the procedure, there was no documented evidence MD4 reviewed Pt1’s care events or spoke with an OB physician regarding the status of Pt1 and her fetus. In accordance with hospital policy, MD4’s pre-procedure OB evaluation documented “no relevant active problems”. There was no documented evidence of patient overall condition, back exam, abdomen exam, fetal age, weight, height, ability to cooperate or laboratory values. There was no documentation of Pt1’s pre-procedure heart rate, blood pressure, respiratory rate, blood oxygen levels or recording of fetal heart rate and patterns. From 6:05 p.m. to 6:38 p.m., the chart indicated the L&D nurses were unable to detect FHT. There was no documented evidence an OBED nurse spoke with an OB physician, or Pt1 received a medical exam or medical stabilization by an OB physician. During a interview and concurrent record review on 4/24/2024 at 3:30 p.m. with Medical Doctor, Anesthesiologist, (MD6), accompanied by CMO and DMS, Patient 1’s medical record provided by the hospital and hospital policies were reviewed and discussed. MD6 stated he has been an anesthesiologist for over 26 years. MD6 stated he is the managing director of the anesthesia agreement with the facility and prior Director of the anesthesia department. MD6 stated the care of the mother and fetus are “hot topics” at the facility. MD6 indicated he is aware of hospital polices, not necessary to review them and stated that “if a policy states a process, need to follow it”. MD6 indicated OB anesthesia services are for the pregnant patient. MD6 stated when a pregnant mom presents for an epidural, there are “two issues, two lives”. MD6 stated “any anesthesia procedures ...anything we [anesthesiologist] do, any procedure, medication ... can affect the fetus and compromise both ... everything is connected [mother and fetus] ...why monitors for fetus and mom” are needed. MD6 stated if there is a problem with fetal heart rate and monitoring, the OB physician is called and an epidural may not be appropriate. MD6 stated the OB nurses are the “first line to assess warning signs” of the mother and fetus. MD6 stated the “RNs job is to monitor FHT” during the epidural and communicate the findings, and if the anesthesiologists believe the fetus or mother are “not doing well”, OB is called to assess the mother and fetus. During a interview and concurrent record review on 4/24/2024 at 2:30 am with Medical Doctor, Anesthesiologist (MD4) accompanied by CMO and DMS, Patient 1’s (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. MD4 stated he has been practicing anesthesia, including OB anesthesia since 1990. MD4 stated the anesthesiologist at the facility are available to provide OB anesthesia and emergency services to patients 24 hours a day, 7 days a week (24/7). MD4 stated if a labor epidural is needed for a patient, the nurse or OB physician will contact the anesthesiologist. MD4 stated the anesthesia care provided to a pregnant woman is a “philosophical issue”. MD4 indicated even if the mother and fetus are one, the fetus is not a patient and “not my concern”. MD4 acknowledged the fetus is dependent on the mother and labor epidurals can affect the mother’s well-being, and in turn, affect the fetus’ well-being. MD4 stated the “customary practice” is to monitor FHT rate and pattern, and mother’s vitals during anesthesia procedures. MD4 acknowledged the hospital policy for OB anesthesiologists required FHT monitoring during anesthesia procedures, but he stated it was “meant for nurses”. MD4 stated the fetus is not a patient and the job of anesthesia is “only the mother”, and the well-being of the unborn baby is the “OB’s and the nurses’ job”. Pt1’s chart and timeline were reviewed with MD4. MD4 acknowledged he provided OB anesthesia services for Pt1 on 3/14/2024 when she arrived on L&D and until 7:10pm. MD4 stated on a nurse “really needed” an “urgent” epidural for Pt1. MD stated Pt1 was “howling” and “screaming”, and “not cooperative”. MD4 acknowledged he did not confirm if an OB physician had evaluated the pregnant mother, OB had determined fetal well-being, OB physician was immediately available, nor reviewed the nurses notes and FHT. MD4 stated it was the “nurse’s job, not anesthesia”. MD4 stated “even if there was a concern with FHT and [baby] status, not my job ...fetal well-being is not my job description ... My job is to place the epidural”. MD4 acknowledged before the epidural placement, there was no documented evidence of maternal vital signs, overall condition of mom, FHT or fetal well-being by the anesthesiologist. MD4’s pre-procedure OB evaluation was reviewed. MD4 documented, “no relevant active problems”. There was no documented evidence of patient overall condition, back exam, abdomen exam, fetal age, weight, height, ability to cooperate or laboratory values. There was no documentation of Pt1’s pre-procedure heart rate, blood pressure, respiratory rate, blood oxygen levels or recording of fetal heart rate and patterns. MD4 stated the anesthesia pre-procedure template note for labor epidurals is “pre-populated” and to complete the chart, “check boxes” in the “electronic” chart. MD4 stated “does not record or look at the FHT”, but “checked the box” as if he did because it was part of the anesthesia ongoing assessment during a labor epidural. During a interview and concurrent record review on 4/25/2024 at 1:00 p.m. with Medical Doctor, Anesthesiologist (MD5), accompanied by CMO, DMS and RNQ2, Patient 1’s medical record provided by the hospital and hospital policies were reviewed and discussed. MD5 state he has been practicing anesthesia for 16 years. MD5 stated he “follows [hospital] policies”. MD5 indicated OB anesthesia provides labor epidurals, pain management and emergency care to pregnant mothers. MD5 stated OB anesthesia’s “primary care is for the mother, and fetus as well”. MD5 stated an anesthesiologist’s training includes “basic FHT” monitoring and interpretation, but the “professional interpretation” is the OB physician’s responsibility. MD5 stated he can “recognize fetal distress and compromise” on FHT monitor tracings and understands the “basic” changes of fetal heart rates on FHT monitors. MD5 stated when procedures are done on the mother by anesthesia, the anesthesiologist “worry about changes in FHTs”. MD5 stated a “decrease in heart rate or increase in heart rate” can reflect “fetal distress and compromise”. MD5 indicated that if he has any concerns about the fetus, he will ask the nurses to call the OB physician and call the “team for help”, because his “primary concern is for the mother”. MD5 stated before starting a labor epidural, he reviews the patient’s history, pregnancy status, obtains consent. The nurses apply monitors for blood pressure, oxygen saturation (measures blood oxygen levels) and FHT. MD5 stated before the procedure MD5 stated that he “looks” at the FHT monitor, checks for “FHT changes” and monitors mother’s vitals, especially for “low blood pressure”, but does not document them. During record review of hospital titled policy, “Department of Anesthesia Rules and Regulations”, approved 11/10/2020 and signed by MEC, Board and Chair of anesthesia department, stated that anesthesiologists “provide medical management of patients ... during surgical, obstetrical, and other medical procedures ... Care will include preoperative, intra-operative, and postoperative evaluation and treatment of these patients ... Anesthesiologists are expected to be familiar with these documents and the standards outlined and follow them in the practice of anesthesiology at [Hospital] ASA (American Society of Anesthesiology) GUIDELINES FOR PATIENT CARE IN ANESTHESIOLOGY, ASA BASIC STANDARDS FOR PREANESTHESIA CARE, ASA STANDARDS FOR BASIC ANESTHETIC MONITORING, ASA STANDARDS FOR POSTANESTHESIA CARE “ During record review of hospital policy titled. “[Hospital] Anesthesiology Clinical Privileges”, approved 7/31/2020, stated the “Core Privileges. Administration of anesthesia, including general, regional, and local [anesthesia ... and the management of emotional stress during surgical, obstetrical and certain other medical procedures; including preoperative, intraoperative and postoperative evaluation and treatment ... Assess, stabilize, and determine disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services. During record review of hospital policy titled “[Hospital] Obstetrical Anesthesia, Index No. O-2”, effective 3/2005, last reviewed 11/2023, stated that anesthesiologist are “committed to providing safe and effective anesthesia ... Regional anesthesia may be performed after the appropriate written consent is obtained from the patient and the attending OB is notified and approval is given ... appropriate lab work must be in the chart ... Fetal heart rate (FHR) must be documented by appropriate personnel before and after the procedure ... Monitoring as stated by the American Society of Anesthesiology must be available and utilized ... the attending OB must be in house prior to the placement of a regional block ... Postoperative care ...the anesthesia provider is responsible”. During record review of hospital titled policy, “[Hospital] Anesthesiology Department Policy and Procedure, Regional Anesthesia, Index No. R-1”, effective 12/2004, last reviewed 11/2023, stated that “Procedure Safety Considerations [include] ... using ASA monitors ...weight and physical condition of the patient ... ...contradictions to performing regional anesthetic include ... inability of the patient to cooperate ...” During record review of hospital policy titled ,”[Hospital] Anesthesiology Department Policy and Procedure, Basic Standards for Pre-anesthesia Care, Index No. B-2”, effective 10/1998, last reviewed 11/2023, stated that anesthesiologist adhere “to the practice standards promulgated by the American Society of Anesthesiologist ... Enhanced patient safety in the perioperative period ... An anesthesia provider shall be responsible for determining the medical status of the patient ...developing a plan of anesthesia care ...Interviewing and examining the patient ... assess those aspects of the physical condition that might affect decisions regarding perioperative risk and management ... obtaining and/or reviewing tests”. During record review, according to Practice Guidelines for Obstetric Anesthesia, the ASA recommends that physicians should be approved through the institutional credentialing process to initiate and direct the maintenance of obstetric anesthesia and to manage procedure related complications. Guidelines includes, but not limited to the following: consultation with the obstetrician who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia. Conducting a relevant obstetrical history and physical examination (maternal health and condition, including airway, heart, lung and back). Obtain laboratory tests. Monitoring vital signs (heart rate, respiratory rate, oxygen blood levels and blood pressure) prior to, during and after administration of labor regional anesthesia, i.e. labor epidural. Perianesthetic recording of fetal heart rate and patterns before, during and after administration of regional anesthesia. Fetal heart rate patterns may change after the administration of neuraxial anesthetics and placing patients at increased risk (e.g., non-reassuring fetal heart rate pattern) Therefore, the patient should remain under continuous direct observation by a provider for at least 20 minutes. https://pubs.asahq.org/anesthesiology/article/124/2/270/12693/Practice-Guidelines-for-Obstetric-Anesthesia (Accessed 4/24/2024) and https://www.asahq.org/standards-and-practice-parameters/statement-on-neuraxial-anesthesia-in-obstetrics (Accessed 4/24/2024) During record review of Patient Care Policy and Procedure for: Women’s and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21”, effective 3/2020, last reviewed 8/2023, stated that “All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing”.”

“INTRAOPERATIVE ANESTHESIA RECORD CFR(s): 482.52(b)(2) [The policies must ensure that the following are provided for each patient:] An intraoperative anesthesia record. This Standard is not met as evidenced by: 42125 Based on interview and record review, in accordance with hospital policy, the 2 of 2 anesthesiologists (physician who provides specialized care before, during and after surgery, procedures to decrease pain, and emergency care), MD 4 and MD 5, failed to provide ongoing evalautions of a labor epidural with continuous medication infusions for one of one patient, (Pt1) and delegated anesthesia tasks to nurses who were not qualified to administer anesthesia. The failure of the anesthesiologist to monitor Pt1’s medical condition and status of the fetus, during the placement of the labor epidural and continuous infusion of epidural medications, missed protentional complications or problems that may have contributed to patient harm and fetal injury. Findings: Record review of Pt1’s medical care on 3/14/2024 from 5:28 p.m. to 11:33 p.m. indicate the following: At 5:28 p.m., the chart indicated Pt1 had a “high” white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11). From 6:05 p.m. to 6:38 p.m., the chart indicated the L&D nurses were unable to detect FHT. There was no documented evidence, an OBED nurse spoke with an OB physician. At 6:05 p.m., there was no documented evidence of FHT. The chart indicated that a labor epidural (when a women is ready to deliver an infant a doctor can place a catheter in the back that infuses medication to decrease labor pain) was requested by nursing staff. There was no documented evidence MD2 communicated with spoke with MD4 and requested the procedure or discussed the status of Pt1 and her fetus. The labor epidural was initiated by MD4. During the placement of the labor epidural and initiating medication, there was no documented evidence that MD4 charted and monitored Pt1’s patient overall condition, heart rate, blood pressure, respiratory rate, blood oxygen levels or recording of fetal heart rate and patterns. The chart indicated the nurse were unable to locate FHT. There was no documented evidence, MD4 interrupted the epidural to determine the status of Pt1 and the fetus. At 6:23 p.m., MD4 completed the epidural. At 6:25 p.m., the nursing exam note indicated, unable to locate FHT, and “no fetal movement”. There was no documented evidence an anesthesiologist or OB physician were at Pt1’s bedside. There was no documented evidence MD4 evaluated Pt1 for a possible emergency when there was concern of fetal compromise and injury. At 6:39 p.m., the chart indicated MD2 was called to the bedside. The chart indicated this was the first evaulation of Pt1 by an OB physician. MD2 documented “no fetal heart tones per” and diagnosed “IUFD [intrauterine fetal demise, death of infant before birth]”. At 7:10 p.m., MD4 turned Pt1’s anesthesia care over to MD5. There is no documented evidence MD4 evaluated Pt1’s status, vitals or condition before signing Pt1 over to MD5. There was no documented evidence MD5 evaluated Pt1’s status, vitals or condition when he assumed care of Pt1’s labor epidural and infusion of medications. There was no documented evidence MD4 or MD5 spoke with an OB physician to discuss the status of Pt1 and the fetus. At 11:26 p.m., the nurse’s note indicated, “meconium” before the delivery of the infant. There was no documented evidence MD5 Pt1’s Pt1’s status, vitals or overall condition during the labor epidural infusion of medications. At 11:33 p.m., MD2 recorded the delivery of the fetus. The record indicated there was a “tight nuchal cord [the umbilical cord connects mother and baby in the womb and supplies blood, oxygen and nutrients to the fetus that gets tangled causing a decrease or absent blood flow] ...noted around the baby’s neck that could not be reduced ...large 6 inch clot noted in [umbilical] cord at the fetal insertion ...[placenta] membranes meconium stained ... cord and placenta [organ in the womb that hold fluid and the fetus] discarded ... infant and patient in delivery room in good and stable condition”. There was no documented evidence MD2 sent fetal remains for examination by a pathologist (a physician who exams tissues and determines abnormal tissue, injury and/or cause of death). During a interview and concurrent record review on 4/24/2024 at 3:30 p.m. with Medical Doctor, Anesthesiologist, (MD6), accompanied by CMO and DMS, Patient 1’s medical record provided by the hospital and hospital policies were reviewed and discussed. MD6 stated he has been an anesthesiologist for over 26 years. MD6 stated he is the managing director of the anesthesia agreement with the facility and prior Director of the department. MD6 stated the care of the mother and fetus are “hot topics” at the facility. MD6 indicated he is aware of hospital polices, not necessary to review them and stated that “if a policy states a process, need to follow it”. MD6 indicated OB anesthesia services are for the pregnant patient. MD6 stated when a pregnant mom presents for an epidural, there are “two issues, two lives”. MD6 stated “any anesthesia procedures ...anything we [anesthesiologist] do, any procedure, medication ... can affect the fetus and compromise both ... everything is connected [mother and fetus] ...why monitors for fetus and mom” are needed. MD6 stated if there is a problem with fetal heart rate and monitoring, the OB physician is called and an epidural may not be appropriate. MD6 stated the OB nurses are the “first line to assess warning signs” of the mother and fetus. MD6 stated if the anesthesiologists believe the fetus or mother are “not doing well”, OB is called to assess the mother and fetus. During a interview and concurrent record review on 4/24/2024 at 2:30 am with Medical Doctor, Anesthesiologist (MD4), accompanied by CMO and DMS, Patient 1’s (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. MD4 stated he has been practicing anesthesia, including OB anesthesia since 1990. MD4 stated the anesthesiologist at the facility available to provide OB anesthesia and emergency services to patients 24 hours a day, 7 days a week (24/7). MD4 stated the anesthesia care provided to a pregnant women is a “philosophical issue”. MD4 indicated even if the mother and fetus are one, the fetus is not a patient and “not my concern”. MD4 acknowledged the fetus is dependent on the mother and labor epidurals can affect the mother’s well-being, and in turn, affect the fetus’ well-being. MD4 stated the “customary practice” is to monitor FHT rate and pattern, and mother’s vitals during anesthesia procedures. MD4 indicated the hospital policies for OB anesthesia and anesthesiologists required FHT monitoring during labor epidurals and patient monitoring were “meant for nurses”. MD4 stated the fetus is not a patient and the job of anesthesia is “only the mother”, and the well-being of the unborn baby is the “OB’s and the nurses’ job”. MD4 acknowledged he did not confirm maternal status of fetal well-being during the epidural placement. MD4 stated the nurse was trying to obtain FHT. MD4 acknowledged he completed the epidural and did not ask the nurse about fetal well-being. MD4 stated “even if there was a concern with FHT and status, not my job ...fetal well-being is not my job description ... My job is to place the epidural”. At 6:23 p.m., MD4 stated the anesthesia procedure template note for labor epidurals is “pre-populated”, with the procedure details and to complete the chart, “check boxes” in the “electronic” chart. MD4 stated “does not record or look at the FHT”, but “checked the box” as if he did because it was part of the anesthesia ongoing assessment during the procedure. MD4 indicated he did not communicate with the OB physician regarding Pt1’s status and completion of the epidural. During and after the placement of the labor epidural and initiating medication, there was no documented evidence MD4 charted and monitored Pt1’s patient overall condition, heart rate, blood pressure, respiratory rate, blood oxygen levels or recording of fetal heart rate and patterns. MD4 stated monitoring Pt1 was the “nurse’s job, not anesthesia”. MD4 stated he usually stays for 20 minutes after the epidural placement, but left. He stated a “few minutes after leaving a nurse ran into the my room” and informed him that the Pt1 needed a “emergency c-section [surgery to remove the fetus from the womb]”. MD4 acknowledged he did not document the communication with the nurse, going to the Pt 1’s bedside, or evaluating Pt1. MD4 indicated he did not evaluate the Pt1 after the labor epidural placement or during the medication infusion. MD4 indicated he transferred Pt1’s care to MD5 on 3/14/2024 at 7:10 p.m. During a interview and concurrent record review on 4/25/2024 at 1:00 p.m. with Medical Doctor, Anesthesiologist (MD5), accompanied by CMO, DMS and RNQ2, Patient 1’s medical record provided by the hospital and hospital policies were reviewed and discussed. MD5 state he has been practicing anesthesia for 16 years. MD5 stated he “follows [hospital] policies”. MD5 indicated OB anesthesia provides labor epidurals, pain management and emergency care to pregnant mothers. MD5 stated OB anesthesia’s “primary care is for the mother, and fetus as well”. MD5 stated an anesthesiologist’s training includes “basic FHT” monitoring and interpretation, but the “professional interpretation” is the OB physician’s responsibility. MD5 stated he can “recognize fetal distress and compromise” on FHT monitor tracings and understands the “basic” changes of fetal heart rates on FHT monitors. MD5 stated when labor epidurals with medications are done for the mother, the anesthesiologist “worry about changes in FHTs”. MD5 stated a “decrease in heart rate or increase in heart rate” can reflect “fetal distress and compromise”. MD5 provided an example of low blood pressure in the mother can cause abnormal “changes in FHTs”. MD5 stated the FHT monitors are watched by the nurses in the room and at the nurses’ station. He explained the nurses’ station monitors all the FHT in one central location on L&D. MD5 indicated the OB nurses notify physicians when FHTs are a concern, the procedure is stopped if necessary. MD5 indicated, if he has any concerns about the fetus, he will ask the nurses to call the OB physician and call the “team for help”, because his “primary concern is for the mother”. MD5 stated during the placement of the labor epidural and continuous infusion of epidural medications, MD5 stated that he “looks” at the FHT monitor, checks for “FHT changes” and monitors mother’s vitals, especially for “low blood pressure”. MD5 stated after the epidural placement, he stays for “10 minutes or until the mother is comfortable” before leaving the bedside. Thereafter, the “mother is assessed at least every 12 hours and as needed”. MD5 stated he signed the chart indicating he was the provided OB anesthesia services for Pt1 during the evening of 3/14/2024. MD5 acknowledged, at 7:10pm he “assumed” the anesthesia care and labor epidural from MD4. MD5 stated anesthesia service ended when the epidural was removed at 11:33 pm. MD5 stated the “nurse is present to oversee” the labor epidurals and “nurses take care of the epidural” and discontinue them. There was no documented evidence in the Pt1’s record that MD5 provided any anesthesia care or assessments during the labor epidural infusion. MD5 stated he “did not check on her [Pt 1]” or provide any medical care during the epidural and infusion of medication during the epidural. Nonetheless, MD5 acknowledged he signed the anesthesia record certifying he provided OB anesthesia care to Pt1 from 7:10pm to 11:33 p.m. During record review of hospital titled policy, “Department of Anesthesia Rules and Regulations”, approved 11/10/2020 and signed by MEC, Board and Chair of anesthesia department, stated that anesthesiologists “provide medical management of patients ... during surgical, obstetrical, and other medical procedures ... Care will include preoperative, intra-operative, and postoperative evaluation and treatment of these patients ... Anesthesiologists are expected to be familiar with these documents and the standards outlined and follow them in the practice of anesthesiology at [Hospital] ASA (American Society of Anesthesiology) GUIDELINES FOR PATIENT CARE IN ANESTHESIOLOGY, ASA BASIC STANDARDS FOR PREANESTHESIA CARE, ASA STANDARDS FOR BASIC ANESTHETIC MONITORING, ASA STANDARDS FOR POSTANESTHESIA CARE “ During record review of hospital policy titled. “[Hospital] Anesthesiology Clinical Privileges”, approved 7/31/2020, stated the “Core Privileges. Administration of anesthesia, including general, regional, and local [anesthesia ... and the management of emotional stress during surgical, obstetrical and certain other medical procedures; including preoperative, intraoperative and postoperative evaluation and treatment ... Assess, stabilize, and determine disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services. During record review of hospital policy titled “[Hospital] Obstetrical Anesthesia, Index No. O-2”, effective 3/2005, last reviewed 11/2023, stated that anesthesiologist are “committed to providing safe and effective anesthesia ... Regional anesthesia may be performed after the appropriate written consent is obtained from the patient and the attending OB is notified and approval is given ... appropriate lab work must be in the chart ... Fetal heart rate (FHR) must be documented by appropriate personnel before and after the procedure ... Monitoring as stated by the American Society of Anesthesiology must be available and utilized ... the attending OB must be in house prior to the placement of a regional block ... Postoperative care ...the anesthesia provider is responsible”. During record review of hospital titled policy, “[Hospital] Anesthesiology Department Policy and Procedure, Regional Anesthesia, Index No. R-1”, effective 12/2004, last reviewed 11/2023, stated that “Procedure Safety Considerations [include] ... using ASA monitors ...weight and physical condition of the patient ... ...contradictions to performing regional anesthetic include ... inability of the patient to cooperate ...” During record review of hospital titled policy ,”[Hospital] Anesthesiology Department Policy and Procedure, Basic Anesthetic Monitoring, Index No. B-1”, effective 10/1998, last reviewed 11/2023, indicated that “these standards apply to all anesthesia care ... This set of standards addresses only the issue of basic anesthetic monitoring, which is one component of anesthesia care ... Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care ... Because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be continuously present to monitor the patient and provide anesthesia care ... Every patient receiving anesthesia shall have the electrocardiogram continuously displayed from the beginning of anesthesia until preparing to leave the anesthetizing location ... During regional anesthesia, the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs .... Every patient receiving anesthesia shall have blood pressure and heart rate determined and evaluated at least every five minutes”. During record review, according to Practice Guidelines for Obstetric Anesthesia, the ASA recommends that physicians should be approved through the institutional credentialing process to initiate and direct the maintenance of obstetric anesthesia and to manage procedure related complications. Guidelines includes, but not limited to the following: consultation with the obstetrician who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia. Conducting a relevant obstetrical history and physical examination (maternal health and condition, including airway, heart, lung and back). Obtain laboratory tests. Monitoring vital signs (heart rate, respiratory rate, oxygen blood levels and blood pressure) prior to, during and after administration of labor regional anesthesia, i.e. labor epidural. Perianesthetic recording of fetal heart rate and patterns before, during and after administration of regional anesthesia. Fetal heart rate patterns may change after the administration of neuraxial anesthetics and placing patients at increased risk (e.g., non-reassuring fetal heart rate pattern) Therefore, the patient should remain under continuous direct observation by a provider for at least 20 minutes. https://pubs.asahq.org/anesthesiology/article/124/2/270/12693/Practice-Guidelines-for-Obstetric-Anesthesia (Accessed 4/24/2024) and https://www.asahq.org/standards-and-practice-parameters/statement-on-neuraxial-anesthesia-in-obstetrics (Accessed 4/24/2024) During record review of Patient Care Policy and Procedure for: Women’s and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21”, effective 3/2020, last reviewed 8/2023, stated that “All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing”.”

“POST-ANESTHESIA EVALUATION CFR(s): 482.52(b)(3) [The policies must ensure that the following are provided for each patient:] A post-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, no later than 48 hours after surgery or a procedure requiring anesthesia services. The post-anesthesia evaluation for anesthesia recovery must be completed in accordance with State law and with hospital policies and procedures, which have been approved by the medical staff and which reflect current standards of anesthesia care. This Standard is not met as evidenced by: 42125 Based on interview and record review, in accordance with hospital policy, for one of one patient, (Pt1) the anesthesiologist (physician who provides specialized care before, during and after surgery, procedures to decrease pain, and emergency care), MD 5, failed to provide a post-operative procedure evaluation who received regional anesthesia and delegated anesthesia tasks to nurses who were not qualified to administer anesthesia. The failure to evaluate Pt1’s post labor epidural evaluation of Pt1’s medical condition and status of the fetus had the protentional to miss complications and determine if anesthesia procedure contributed to patient harm, fetal compromise or elevated white count (sign of infection). Findings: Record review of Pt1’s medical care of indicate the following: On 3/14/2024 at 11:33 p.m., the OB physician recorded the delivery of nonviable infant . The chart indicated discontinuation of epidural medication and epidural catheter removal and the post-procedure anesthesia evaluation was completed by the nurses. There was no documented evidence MD5 evaluated Pt1 after delivery of the infant, discontinuation of the labor epidural medications or removal of the catheter tube. On 3/15/2024 at 2:16 a.m., review of the patient’s chart, indicated Pt1 had a “high” white count of 18.2, increased from 13.7 (normal 5.5-11) a few hours earlier. There was no documented evidence MD5 evaluated Pt1 for possible infection and risks after a labor epidural. During a interview and concurrent record review on 4/24/2024 at 3:30 p.m. with Medical Doctor, Anesthesiologist, (MD6), accompanied by CMO and DMS, Patient 1’s medical record provided by the hospital and hospital policies were reviewed and discussed. MD6 stated he has been an anesthesiologist for over 26 years. MD6 stated he is the managing director of the anesthesia agreement with the facility and prior Director of the department. MD6 stated the care of the mother and fetus are “hot topics” at the facility. MD6 indicated he is aware of hospital polices, not necessary to review them and stated “if a policy states a process, need to follow it”. During a interview and concurrent record review on 4/25/2024 at 1:00 p.m. with Medical Doctor, Anesthesiologist (MD5), accompanied by CMO, DNS and RNQ2, Patient 1’s medical record provided by the hospital and hospital policies were reviewed and discussed. MD5 state he has been practicing anesthesia for 16 years. MD5 stated he “follows [hospital] policies”. MD5 indicated OB anesthesia provides labor epidurals, pain management and emergency care to pregnant mothers. MD5 stated OB anesthesia’s “primary care is for the mother, and fetus as well”. MD5 stated when procedures are done on the mother by anesthesia, the anesthesiologist “worry about changes in FHTs”. MD5 stated a “decrease in heart rate or increase in heart rate” can reflect “fetal distress and compromise”. MD5 provided an example of low blood pressure in the mother. MD5 indicated, if he has any concerns about the fetus, he will ask the nurses to call the OB physician and call the “team for help”, because his “primary concern is for the mother”. MD5 stated he signed the chart indicating he was the provided OB anesthesia services for the night of 3/14/2024 for Pt1. MD5 acknowledged, at 7:10pm he “assumed” the anesthesia care and labor epidural from MD4. MD5 stated anesthesia care ended when the epidural catheter was removed at 11:33 pm. MD5 stated the “nurse is present to oversee” the labor epidurals and “nurses take care of the epidural” and discontinue them. MD5 stated the nurse will document in the anesthesia record the anesthesia “stop time” when they have stopped the medication, removed the epidural catheter and completed the note. The nurse will forward the note for a physician signature. MD5 stated he “checks the dashboard [notes that need to signed in the computer]” to sign the note from the nurses. The MD5 stated he will sign the note after the nurse have completed the post-procedure entries and evaluation. MD5 acknowledged he signed the post “Procedure Summary” at 12:04, certifying he provided OB anesthesia care to Pt1 from 7:10pm to 11:33 p.m. There was no documented evidence in the Pt1’s record that MD5 provided any anesthesia care or assessments after removal of the epidural catheter or provided a post-procedure examination on 3/15/2024. MD5 stated he “did not check on her [Pt1] during the epidural”, after the removal of the epidural by the nurses or provide a post-procedure exam. During record review of hospital titled policy, “Department of Anesthesia Rules and Regulations”, approved 11/10/2020 and signed by MEC, Board and Chair of anesthesia department, stated that anesthesiologists “provide medical management of patients ... during surgical, obstetrical, and other medical procedures ... Care will include preoperative, intra-operative, and postoperative evaluation and treatment of these patients ... Anesthesiologists are expected to be familiar with these documents and the standards outlined and follow them in the practice of anesthesiology at [Hospital] ASA (American Society of Anesthesiology) GUIDELINES FOR PATIENT CARE IN ANESTHESIOLOGY, ASA BASIC STANDARDS FOR PREANESTHESIA CARE, ASA STANDARDS FOR BASIC ANESTHETIC MONITORING, ASA STANDARDS FOSR POSTANESTHESIA CARE “ During record review of hospital policy titled. “[Hospital] Anesthesiology Clinical Privileges”, approved 7/31/2020, stated the “Core Privileges. Administration of anesthesia, including general, regional, and local [anesthesia ... and the management of emotional stress during surgical, obstetrical and certain other medical procedures; including preoperative, intraoperative and postoperative evaluation and treatment ... Assess, stabilize, and determine disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services. During record review of hospital policy titled “[Hospital] Obstetrical Anesthesia, Index No. O-2”, effective 3/2005, last reviewed 11/2023, stated that anesthesiologist are “committed to providing safe and effective anesthesia ... Monitoring as stated by the American Society of Anesthesiology must be available and utilized ... Postoperative care ...the anesthesia provider is responsible”. During record review of hospital policy titled ,”[Hospital] Anesthesiology Department Policy and Procedure, Basic Standards for Pre-anesthesia Care, Index No. B-2”, effective 10/1998, last reviewed 11/2023, stated that anesthesiologist adhere “to the practice standards promulgated by the American Society of Anesthesiologist ... Enhanced patient safety in the perioperative period ... An anesthesia provider shall be responsible for determining the medical status of the patient ...developing a plan of anesthesia care ...Interviewing and examining the patient ... assess those aspects of the physical condition that might affect decisions regarding perioperative risk and management ... obtaining and/or reviewing tests”. During record review, according to Practice Guidelines for Obstetric Anesthesia, the ASA recommends that physicians should be approved through the institutional credentialing process to initiate and direct the maintenance of obstetric anesthesia and to manage procedure related complications. Guidelines includes, but not limited to the following: consultation with the obstetrician who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia. Conducting a relevant obstetrical history and physical examination (maternal health and condition, including airway, heart, lung and back). Obtain laboratory tests. Monitoring vital signs (heart rate, respiratory rate, oxygen blood levels and blood pressure) prior to, during and after administration of labor regional anesthesia, i.e. labor epidural. Perianesthetic recording of fetal heart rate and patterns before, during and after administration of regional anesthesia. Fetal heart rate patterns may change after the administration of neuraxial anesthetics and placing patients at increased risk (e.g., non-reassuring fetal heart rate pattern) Therefore, the patient should remain under continuous direct observation by a provider for at least 20 minutes. https://pubs.asahq.org/anesthesiology/article/124/2/270/12693/Practice-Guidelines-for-Obstetric-Anesthesia (Accessed 4/24/2024) and https://www.asahq.org/standards-and-practice-parameters/statement-on-neuraxial-anesthesia-in-obstetrics (Accessed 4/24/2024)”

“INTEGRATION OF EMERGENCY SERVICES CFR(s): 482.55(a)(2) [If emergency services are provided at the hospital --] (2) The services must be integrated with other departments of the hospital. This Standard is not met as evidenced by: 42125 Based on observation, interview and record review, and in accordance with hospital policies, the emergency department (ED) failed to ensure timely and appropriate obstetric (OB- care to pregnant mothers and unborn infants) emergency screening exam (MSE) for an emergency medical condition (EMC) was provided by a licensed physician, but instead delegated emergent medical care to nurses (RN) who were not qualified physicians. This failure allowed non-physician RNs to diagnosis and provide medical screening exams, medical stabilization, orders and other emergent medical services without OB physician oversight and placed patient safety and medical care in jeopardy for one of one patient and her fetus (Pt1). Findings: Record review of Pt1’s OB emergency department (OBED) medical care on 3/14/2024 from 4:38 p.m. to 5:42 p.m. indicate the following: On 3/14/2024 at 4:38 p.m., the chart indicated Pt1 arrived at the OBED in “Labor [signs indicating ready to give birth]” and was placed in a room. At 4:45 p.m., the chart indicated a RN (nurse) placed orders for medications, intravenous (I.V.- given via a vein) fluids and monitors, and provided a diagnosis and started to carry out her orders for Pt1. There was no documented evidence, an OBED nurse spoke with a physician. There was no documented evidence a medical screening examination (MSE) by a physician occurred for an emergency medical condition (EMC). At 5:00 p.m., the nurses documented, Pt1 was placed on a fetal heart monitor for (FHT- measures character, pattern and rate of a fetus’ heartbeat. A normal heartbeat fluctuates between110 to 160 that increase and decrease with sleep, activity and contractions and signals fetal well-being). FHT were measured at 140 beats per minute without the normal heart rate fluctuations (a signal of fetal harm and distress). There was no documented evidence a MSE examination or stabilization an EMC was provided by a physician. At 5:05 p.m., chart indicated verbal orders were “authorized” by MD1 and indicated that the OB physician was to be notified for meconium (fetal stool), fetal heart rate abnormalities per policy. There was no documented evidence MD1 spoke with a nurse or examined the Pt1. At 5:09 p.m., chart indicated MD2 ordered I.V. fluids with instructions: “May increase to 500mL bolus [large volume of I.V. fluid given rapidly] for abnormal fetal heart rate patterns”. There was no documented evidence MD2 spoke with a nurse or examined the Pt1. At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and “therapeutic touch”. At 5:28 p.m., the nurses documented Pt1’s complaints of pain “7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation. At 5:28 p.m., the chart indicated Pt1 had a “high” white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11). At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1. At 5:41 p.m., the chart indicated MD2 signed Pt1’s orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1. At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1. During a interview and concurrent record review on 4/25/2024 at 9:00 a.m. with Medical Doctor, Emergency Department Director (MD3) accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), hospital policies were reviewed and discussed, but MD 3 could not see the records due to technology. MD3 stated he was the medical director for the hospital emergency department (ED). MD3 stated there should “always” be a physician in the ED, and there is “never” a case when there is not. MD3 stated indicated that he understood EMTALA (Emergency Medical Treatment and Labor Act) requirements and hospital policies. MD3 indicated patients who arrive at the ED are screened for an EMC, provided a MSE and stabilizing medical treatment. MD3 stated the patient is the responsibility of the physician and medical care is provided “as soon as you can”. MD3 stated an EMC, MSE and stabilization of patient is “not done the over the phone” by a physician and “nobody [patient] leaves the department without a face-to-face evaluation”. MD3 stated a pregnant woman in labor who arrive in the OBED or ED, EMTALA requirements still apply. MD3 indicated OB patients can be seen in the main ED and are provided a MSE and stabilization. If the complaint labor or pregnancy related, after triage, the patient is “escorted” by ED staff to the OBED. On the other hand, a pregnant women go directly to the OBED for an EMC, receive an MSE and stabilizing treatment by an OB physician and it’s “not done by phone”. During an interview and concurrent record review on 4/24/2024 at 11:30 a.m. with Medical Doctor (MD), Obstetrician (physician who provides medical care to pregnant mothers and unborn infants), accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), Patient 1’s (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. The Medical Doctor, Obstetrician (MD2), stated she “understands hospital policies ...been at the hospital for twenty years” and EMTALA. MD2 stated a patient with an EMC needs to be seen by the physician “within 30 minutes” of arrival. MD2 acknowledged she was responsible physician for the OB emergency services, MSE and stabilization of OB patients, and not the nurses. MD2 indicated that the OBED was a unit that evaluated emergency pregnant patients, determined their acuity, diagnosed medical issues, made a plan of care, managed and stabilized them. MD2 stated a woman in labor (ready to deliver a baby) is considered a “medical emergency condition [EMC]”, and the patient requires a medical screening exam (MSE) and stabilization of an EMC. MD2 explained the process for evaluating EMC and providing a MSE. MD2 stated “nurses are “qualified” to complete MSE and provide stabilizing medical treatment. MD2 stated the patient will be “seen by the nurses”, and if the “RN needs direction, it is given over the phone”. MD2 stated if she “can’t see the patient ...over the phone ...give directions” to the nurse. MD2 stated the physician “doesn’t need to see the patient”, and this has been the “standard” for years at the hospital. MD2 stated that nurses are allowed to place “verbal orders” for medications, monitors, intravenous fluids, treatments and provide an admitting diagnosis for a patient in the computer without a physician evaluation or communication. MD2 stated that she “signs 100’s of orders” from the nurses that “pop-up” in her computer “inbox” and one of her “chores” is to e-sign (electronically sign) and approve orders from nurses. MD2 indicated she does not evaluate patients that she signs verbal orders for, nor determine who the orders are for or why they were ordered by the nurse. MD2 stated she “doesn’t call the nurses when verbal orders are placed by the nurse ... I sign the orders” for nurses. MD2 stated fetal (unborn baby) heart tones (FHT, character, pattern and rate of a fetus’ heart) are “important to monitor” and reflect the “well-being of the infant”. MD2 explained abnormal and changes FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 stated a “nuchal cord [the umbilical cord connects mother and baby in the womb and supplies blood, oxygen and nutrients to the fetus] can get tangled and there is a decrease or absent blood flow”. It can become “tight enough” to limit or stop blood and oxygen delivery to the unborn infant and can be “tight enough to be fatal”. MD2 indicated if a fetus expels “meconium (fetal stool)”, it is abnormal and a sign of fetal distress. MD2 stated discussing Pt1’s care was a “loaded question”. MD2 acknowledged Pt1 was admitted to the OBED in “labor” and had an EMC. MD2 stated she was “available” to see Pt1 when she arrived at the emergency department for obstetrics (OBED) at 4:39 p.m., but the nurses provided the MSE. The chart indicted MD2 signed verbal orders for the nurses at 5:41 p.m. MD2 acknowledged she, during Pt1’s stay in the OBED did not communicate with the nurse about the Pt1’s status and EMC, nor ask the nurses about the orders placed or admitting diagnosis. MD2 stated she “doesn’t call the nurses when verbal orders are placed by the nurse”. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD2. MD2 stated that she “never saw” the FHT monitor strips (recordings of fetal heart tones) during Pt1’s OBED admission. MD2 indicated OB RNs were “qualified” to interrupt, diagnose and act upon abnormal FHT. MD2 stated FHT record strips at 5:00 p.m. to 5:42 p.m. were “not normal” because there was “no reaction” of the baby to contractions or other signals of fetal well-being. MD2 acknowledged she did not evaluate Pt1’s status, fetal well-being or FHT. MD2 acknowledged the tracings that did not improve and “could signal an emergency” for the fetus and/or mother. MD2 acknowledged that she did not provide a MSE for Pt1 and her fetus’ emergency needs. MD2 indicated the nurses provided the MSE for an EMC and interruption of FHT. During a interview and concurrent record review on 4/24/2024 at 4:45 p.m. with Medical Doctor, Obstetrician and Department Director (MD1), accompanied by the CMO and MRA, hospital policies were discussed and reviewed. MD1 stated he was the Director of the OB department. MD1 stated indicated he understood EMTALA requirements and OB policies. MD1 indicated that he was not in agreement with hospital policies regarding the response time requirements to provide patients with an evaluation and time requirements to address maternal and/or fetal comprise and distress. MD1 stated the OBED physician will evaluate patients who arrive at the emergency department, but the evaluation time “expectation is a tricky question ...and depends”. MD1 stated the “physicians and nurses do a great job ...experienced ... the hospital is not unsafe”. MD1 stated the “concerns” on the OB floors are related to “problems caused by [hospital] management”. MD1 indicated that management “hired nurses” to work on OB floor who have “zero management oversite” of the care they provided, and some nurses “do not know how to put on monitors and didn’t know what was going on” with pregnant mothers and fetal status. MD1 explained the “normal process” in the OBED. MD1 stated OB RNs are “QMP [non-physician qualified medical providers; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries]”. The RN completes MSE for EMCs. MD1 stated the “standard for years” at the hospital has allowed the nurses to use their “judgment” to diagnosis, order medications and treatments, and admit to patients in order to “expedite” medical care that may otherwise be “delayed”. MD1 stated continuous FHT monitors “make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay”. MD1 indicated OB nurses are qualified to interrupt, diagnose and respond to abnormal FHT. After the nurse has provided a MSE, without physician evaluation or communication, the nurses will place orders, as “verbal orders”, for medications, monitors, intravenous fluids, treatments, diagnosis and admit patients. The orders written by the nurses are sent to the physicians “in box” electronically and the physician will sign them up to 2 days later. MD1 stated he receives “100’s of orders [written by nurses] and do not check who they are from ... it is difficult to verify who and what the orders are for ...just sign-off” without review. At some time, the nurses will “talk with the physician” about the patient’s status. MD1 indicated that he was Pt1’s primary OB provider throughout her pregnancy and was listed inpatient provider on 3/14/2024 from 4:46 p.m. to 3/15/2024 3:10 p.m. MD1 acknowledged Pt1 was in labor when she arrived in the OBED at 4:38 p.m. and had a EMC. MD1 acknowledged at 5:00 p.m. Pt1’s FHT were abnormal. The records indicated MD1 “authorized” nurse to place orders under his name for Pt1 on 3/14/2024 as early as 5:05 p.m. MD1 stated he did not evaluate Pt1 or discuss her status with the nurses. MD1 stated he only evaluated Pt1 on 3/15/2024. MD1 acknowledged, on 3/14/2024 MD2 was on call for labor and delivery emergencies and the OB emergencies in the OBED. MD1 acknowledged MD2 did not provide Pt1 care in the OBED, did not provide a MSE for Pt 1’s EMC, and it “longer than expected” for Pt1 to be evaluated by MD2. During record review of the hospital policy titled, Department of OB-GYN [obstetrics (OB)- care of pregnanat women & Gynecology (GYN) women’s reproductive system] /Perinatology, [care of pregnant mothers-woman’s heath/care of fetus, unborn baby], Rules and Regulations”, effective 5/2012, last reviewed 8/2023, stated that “OB-GYN is organized as a major department of the Medical Staff, encompassing obstetrics, gynecology, perinatology, pediatrics [care of children] and neonatology [care of newborns] ... High risk Ob-Gyn cases will be managed by an individual who has completed a fully approved residency training program in Obstetrics & Gynecology ... The OBED will work to collaborate with the Emergency Department ... EMTALA requirements related to obstetric care should be as follows: 1. A medical screening examination (MSE) must be performed by an appropriately privileged physician to determine whether the patient has an emergency medical condition ...An appropriately trained labor and delivery nurse is qualified by virtue of his/her training to perform the medical screening exam to determine the presence of labor”. During record review of hospital policy titled “[Hospital] Emergency Medical Treatment and Labor Act (EMTALA) Compliance, Index No. A-11” approved July 2023, stated an “Emergency Medical Condition (“EMC”): A medical condition manifesting itself by acute symptoms of sufficient severity ...such that the absence of immediate medical attention could reasonably be expected to result in ...placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy ... A pregnant woman who is having contractions is considered to have an EMC”. During record review of hospital policy titled “[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5”, effective June 2014, last reviewed 4/2020, stated that “assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay”. During record review of hospital policy titled “[Hospital] OB Emergency Services Standardized Procedure, Standardized Procedure: OB Medical Screening Examination index No. G-3”, effective June 2014, last reviewed 1/2022, stated that “ Supervision: The OB ED physician or patient’s primary OB physician will provide supervision... A pregnant individual having contractions is considered to have an emergency medical condition ... ‘Emergency medical condition’ means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the pregnant woman and/or her unborn child in serious jeopardy ... Diagnosis: Physician is to give a diagnosis on all patients receiving a MSE in OBED”. During record review of hospital policy titled “Bylaws of the Medical staff for [Hospital]”, effective 1/27/20212, amendment effective 7/27/20218 indicated the “BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP providing patients with the quality of care meeting the professional standards of the Medical Staff ... abiding by these Bylaws, the Medical Staff Rules and Regulations, the departmental Rules and Regulations, and the Policies and Procedures of the Medical Staff ... complying with all Federal and State statutes ... preparing and completing accurate and complete medical records including electronic records ... updated examination of the patient, including any changes in the patient’s condition, must be completed and documented by a physician ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders ... No patient shall be admitted to the Hospital until a provisional diagnosis or valid reason for admission has been stated by the admitting physician ... Each Medical Staff Member must assure timely, adequate, professional care for his patients in the Hospital”. During record review of Patient Care Policy and Procedure for: Women’s and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21”, effective 3/2020, last reviewed 8/2023, stated that “All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing”. The tables in the policy indicated management of possible FHR patterns: Category I: Routine management. Normal FHR baseline between 110 and 160 bpm with variability (10 to 25 bpm increase or decrease of FHR with sleep, activity and mother’s contractions). Also considered “reassure” fetal well-being. Category II: Absent FHR acceleration (normal increase is 10 - 25 bpm from bassline and maximum HR of less than 160 bpm) and/or absent/minimal FHR variability (Amplitude range undetectable and ? (less or equal to) 5 bpm (heart beat per minute] variability. Tachycardia (fast heart rate) Baseline rate greater than160 bpm. If FHR do not improve consider delivery. Category III FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing do not improve, consider prompt delivery.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 42125 The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff they provide stabilizations and ongoing evalautions for OB and L&D patients. Based on observation, interview and record review, and in accordance with hospital policies, the emergency department (ED) failed to ensure ongoing assessments and stabilization of emergent obstetric (OB- pregnant woman and unborn baby) patients was provided by a licensed physician, but instead OBED medical care were provided by unsupervised nurses (RNs). This failure allowed RNs to determine the ongoing emergency medical needs and stabilization of one of one patient and her unborn fetus (Pt1) without physician direction, oversight and orders which placed patient safety and medical care in jeopardy of one of one patient (Pt1). Findings: Record review of Pt1’s OB emergency department (OBED) medical care on 3/14/2024 from 5:20 p.m. to 6:39 p.m. indicate the following: The chart indicate Pt1 spent 86 minute (4:38 p.m. to 6:04 p.m.) in the OBED plus 33 minutes in L&D before being evaluated by a physician for a medical emergency. At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and “therapeutic touch”. At 5:28 p.m., the nurses documented Pt1’s complaints of pain “7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation. At 5:28 p.m., the chart indicated Pt1 had a “high” white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11). At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1. At 5:41 p.m., the chart indicated MD2 signed Pt1’s orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1. At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1. At 5:56 p.m., the nurses documented Pt1’s complaints of “cramping”, “worsening” and pain “7/10”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician examined the Pt1. At 6:02 p.m. the nurses documented fetal heart rate 145 bpm with continued variable deceleration without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence of FHT monitoring strips from 5:42 p.m. onward. There was no documented evidence an OBED nurse spoke with an OB physician. There was no documented evidence an OB physician provided a MSE or stabilization for an EMC prior to Pt1 leaving the OBED. At 6:04 p.m., the chart indicated Pt1 was admitted to Labor and Delivery (L&D) floor and transferred from the OBED. There was no documented evidence Pt1 received a medical exam or medical stabilization by an OB physician on arrival to L&D. At 6:39 p.m., the chart indicated MD2 was called to the bedside. The chart indicated this was the first evaulation of Pt1 by an OB physician. MD2 documented “no fetal heart tones per” and diagnosed “IUFD [intrauterine fetal demise, death of infant before birth]”. During an interview and concurrent record review on 4/24/2024 at 11:30 am with Medical Doctor (MD), Obstetrician (physician who provides medical care to pregnant mothers and unborn infants), accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), Patient 1’s (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. The Medical Doctor, Obstetrician (MD2), stated she “understands hospital policies ...been at the hospital for twenty years”. MD2 indicated she understood responsibilities of EMTALA and OB patient care requirements. MD2 indicated that OBED was a unit that evaluated emergency pregnant patients, determined their acuity, diagnosed medical issues, made a plan of care, provided stabilizations and ongoing assessments. MD2 stated a woman in labor is considered a “medical emergency condition”, and after a MSE requires stabilization and ongoing assessments. Pt1’s timeline of events was reviewed with MD2. MD2 stated discussing Pt1’s care was a “loaded question”. MD2 stated that on 3/14/2024 on call she was on call for the OBED and L&D emergencies and was responsible for evaluation, stabilizations and ongoing assessments of OB patients, and not the nurses. MD2 stated that Pt1 was in labor on arrival to the OBED and had a EMC that required stabilization and ongoing assessments. MD2 stated that nurses are “qualified” to provide stabilizing medical treatment for an EMC and if the “RN needs direction, it is given over the phone”. MD2 stated the physician “doesn’t need to see the patient”, and this has been the “standard” for years at the hospital. MD2 stated, without a physician’s ongoing evaluation of an OBED patient, nurses are allowed to place orders as “verbal orders” for medications, monitors, intravenous fluids, and treatments for a patient in the computer. MD2 stated that she “signs 100’s of orders” from the nurses that “pop-up” in the computer “inbox” and one of her “chores” is to e-sign (electronically approve) and approve orders from nurses. MD2 indicated she does not evaluate patient she signs verbal orders for or determine who the orders are for or why they were ordered by the nurse. MD2 acknowledged at 5:41 p.m., she signed Pt1’s nursing orders. MD2 acknowledged she did not call the nurse about the PT1’s status and emergency medical condition. MD2 stated she “doesn’t call the nurses when verbal orders are placed by the nurse ...I sign the orders” for nurses. Review of the patient’s chart, indicated Pt1 had a “high” white count (WBC, a sign of an infection) of 13.7 (normal 5.5-11) on 3/14/2024 at 5:28 p.m. and 18.2 on 3/15/2024 at 2:16 a.m. There was no documented evidence MD2 reviewed the labs, provided an interruption of the labs or initiated care to Pt1. MD2 stated ongoing fetal (unborn baby) heart tones (FHT, character, pattern and rate of a fetus’ heart) are “important to monitor” and reflect the “well-being of the infant”. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise and require emergency intervention to ensure the life and safety of the fetus and mother. MD2 indicated if a fetus expels meconium (fetal stool), it is abnormal and a sign of fetal distress. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 indicated OB RNs are “qualified” to interrupt, diagnose and act upon abnormal FHT, but are not physicians. Thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries. MD2 stated OB RNs are “qualified” to interrupt and diagnose FHTs. The chart indicated while Pt1 was in the OBED, for 85 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations. The FHT record strips from 5:00 p.m.to 5:42 p.m. were reviewed with MD2. According to nursing documentation, variable decelerations were still present at 6:02 p.m. MD2 stated that she “never saw” the FHT monitor strips (recordings of fetal heart tones) during Pt1’s hospital admission. MD2 stated the Pt1’s FHT tracing strips were “not normal” because there was “variable deceleration”, “no reaction” of the baby to contractions or other signals of fetal well-being. MD2 acknowledged the tracings that did not improve and “could signal an emergency” for the fetus and/or mother. MD2 acknowledged that on 3/14/2024 she was on call to provide medical services and “responsible” physician for the OB emergency services and ongoing evaluations and stabilization of OB patients, and not the nurses. MD2 acknowledged that she did not provide stabilizing medical care and ongoing assessments for Pt1’s or determine emergency needs of the fetus during their 85 minute stay in the OBED. MD2 indicated the nurses provided the ongoing evalautions and orders for Pt1’s EMC and interrupt and respond to abnormal FHT. During a interview and concurrent record review on 4/24/2024 at 4:45 p.m. with Medical Doctor, Obstetrician and Department Director (MD1), accompanied by CMO) and MRA, Patient 1’s medical record provided by the hospital and hospital policies were discussed and reviewed. MD1 stated he was the Director of the OB department. MD1 stated that he understood EMTALA requirements and OB policies. MD1 stated the “physicians and nurses do a great job ...experienced ... the hospital is not unsafe”. MD1 stated the “concerns” on the OB floors are related to “problems caused by [hospital] management”. MD1 indicated that management “hired nurses” to work on OB floor and have “zero management oversite” of the care they provided, and some nurses “didn’t know how to put on monitors and didn’t know what was going on” with pregnant mothers and fetal status. MD1 explained the “normal process” in the OBED. MD1 stated OB RNs are “QMP [non-physician qualified medical provide; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries]” and after the RN completes the medical screening exam (MSE), they provide stabilizations and ongoing evalautions for OB and L&D patients. MD1 stated the “standard for years” at the hospital has allowed the nurses to use their “judgment” to diagnosis, order medications and treatments, and admit to patients in order to “expedite” medical care that may otherwise be “delayed”. After the nurse has provided a MSE, without physician evaluation or communication, the nurses will place orders, as “verbal orders”, for medications, monitors, intravenous fluids, treatments, diagnosis and admit patients. The orders written by the nurses are sent to the physicians “in box” electronically and the physician will sign them up to 2 days later. MD1 stated he receives “100’s of orders [written by nurses] and do not check who they are from ... it is difficult to verify who and what the orders are for ...just sign-off” without review. At some time, the nurses will “talk with the physician” about the patient’s status. It’s “standard procedure” at the hospital. MD1 stated continuous FHT monitors “make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay”. MD1 stated he does not agree with the time recommended to intervene for abnormal FHT tracings that last greater than 20 minutes. The hospital policy titled Patient Care Policy and Procedure for: Women’s and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21” was reviewed with MD1.It indicated management of possible FHR patterns: Category I (CAT1): Routine management. Normal FHR baseline between 110 and 160 bpm (heart beat per minute) with variability (an increase or decrease of 6 to 25 bpm of FHR with sleep, activity and mother’s contractions MD1 stated CAT1 “reassures” fetal well-being. Category II (CAT2): Absent FHR acceleration (normal increase is 6 - 25 bpm from bassline with a maximum HR of 160 bpm) and/or absent or minimal FHR variability (amplitude (height) range undetectable and less or equal to 5 bpm variability. Tachycardia (fast heart rate greater than 160). “ If FHR do not improve consider delivery”. MD1 acknowledged that the CAT 2 tracing could change to CAT 3 emergency tracings. Category III (CAT3): FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing “do not improve, consider prompt delivery”. MD1 stated he was not in agreement with the time limitations. The chart indicated for 62 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations and after for another 25 minutes FHT could not be located. MD1 stated continuous FHT monitors “make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay”. MD1 indicated OB nurses are qualified to interrupt, diagnose and respond abnormal FHT. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD1 MD1 stated the first variable deceleration was at 5:36 p.m., and FHT monitoring records were not available after 5:48 p.m. According to nursing documentation, variable deceleration were still present at 6:02 p.m. MD1 stated after 5:48 p.m., “something happened” to the baby” and fetal well-being “could not be determined”. MD1 acknowledged that FHT tracing were abnormal and could have required emergency intervention. MD1 stated he does not agree with policy that a physician should evaluate and intervene if abnormal FHT tracings last greater than 20 minutes. MD1 indicated OB nurses are qualified to interrupt, diagnose and respond to abnormal FHT. MD1 stated if the nursing staff were “not worried” about FHT than “nothing is done MD1 indicated was the primary OB provider for Pt1 on 3/14/2024 from 4:46 p.m. to 3/15/2024 3:10 p.m., because he had been her physician throughout pregnancy. The records indicated MD1 “authorized” nurse to place orders under his name for Pt1 on 3/14/2024 as early as 5:05 p.m. MD1 stated he did not evaluate Pt1 or discuss her status with the nurses. MD1 stated he only evaluated Pt1 on 3/15/2024. MD1 indicated that OB emergency medical services and ongoing evaluations and stabilization of Pt1 and her fetus was provided nurses, and not physicians. MD1 stated “during root cause analysis (RCA, a process to uncover causes of problems) and interview with the nurses”, they reported “heard FHT”, but there were no FHT strips. MD1 indicated hearing noise does not determine fetal well-being. MD1 stated the Pt1 was removed from the monitors at 5:48 p.m. and it appeared “the fetus was alive when left the OBED but not properly monitored in the OBED after 5:48 p.m. and not on L&D”. MD1 acknowledged MD2 did not provide Pt1 care in the OBED, did not evaluate Pt 1’s EMC, provide MSE or stabilization. MD1 stated it took “longer than expected” for Pt1 to be evaluated by MD2. MD1 stated, even if Pt1 had a timely MSE evaluated by EDOB physician, MD2 evaluated the well-being of the fetus, and Pt1 had continuous FHT, it “would not have made a difference in the outcome ...fetal demise would have occurred”. It was “unfortunate”. MD1 stated the hospital provides “safe care”. During a interview and concurrent record review on 4/25/2024 at 9:00 a.m. with Medical Doctor, Emergency Department Director (MD3) accompanied by CMO and DMS hospital policies were reviewed and discussed, but MD 3 could not see the records due to technology. MD3 stated he was the medical director for the hospital emergency department (ED). MD3 stated there should “always” be a physician in the ED, and there is “never” a case when there is not. MD3 stated indicated that he understood EMTALA requirements and hospital policies. MD3 indicated patients who arrive at the ED are screened for an EMC, provided a MSE and stabilizing medical treatment. MD3 stated the patient is the responsibility of the physician and medical care is provided “as soon as you can”. MD3 stated an EMC, MSE and stabilization of patient is “not done the over the phone” by a physician and “nobody [patient] leaves the department without a face-to-face evaluation”. MD3 stated a pregnant woman in labor who arrive in the OBED or ED, EMTALA requirements still apply. MD3 indicated OB patients can be seen in the main ED and are provided a MSE and stabilization. If the complaint labor or pregnancy related, after triage, the patient is “escorted” by ED staff to the OBED. On the other hand, a pregnant women go directly to the OBED for an EMC, receive an MSE and stabilizing treatment by an OB physician and it’s “not done by phone”. During record review of the hospital policy titled, Department of OB-GYN [obstetrics (OB)- care of pregnant women & Gynecology (GYN) women’s reproductive system] /Perinatology, [care of pregnant mothers-woman’s heath/care of fetus, unborn baby], Rules and Regulations”, effective 5/2012, last reviewed 8/2023, stated that “High risk Ob-Gyn cases will be managed by an individual who has completed a fully approved residency training program in Obstetrics & Gynecology ... Obstetrical Emergency Department (OBED) located in a designated location on the obstetrical unit to be assessed for medical conditions ... The OBED will work to collaborate with the Emergency Department ... EMTALA requirements related to obstetric care should be as follows ... If an emergency medical condition exists, patient must be stabilized and transferred to the labor unit or appropriate acute care hospital department”. During record review of hospital policy titled “[Hospital] Emergency Medical Treatment and Labor Act (EMTALA) Compliance, Index No. A-11” approved July 2023, stated an “Emergency Medical Condition (“EMC”): A medical condition manifesting itself by acute symptoms of sufficient severity ...such that the absence of immediate medical attention could reasonably be expected to result in ...placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy ... A pregnant woman who is having contractions is considered to have an EMC ...To Stabilize or Stabilized: No material deterioration of the EMC is likely”. During record review of hospital policy titled “[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5”, effective June 2014, last reviewed 4/2020, stated that “assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay ...Therapies, procedures and interventions that are conducted in the OBED include, but are not limited to: Recognition, interpretation and recording of patient vital signs and symptoms, particularly those that require immediate notification of a physician [and] Physician Oversight ... Patients in labor will be transferred to the Labor and Delivery unit after an appropriate medical screening examination and stabilization in accordance with EMTALA regulations”. During record review of hospital policy titled “[Hospital] OB Emergency Services Standardized Procedure, Standardized Procedure: OB Medical Screening Examination index No. G-3”, effective June 2014, last reviewed 1/2022, stated that “ Supervision: The OB ED physician or patient’s primary OB physician will provide supervision... A pregnant individual having contractions is considered to have an emergency medical condition ... ‘Emergency medical condition’ means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the pregnant woman and/or her unborn child in serious jeopardy ... Diagnosis: Physician is to give a diagnosis on all patients receiving a MSE in OBED. During record review of hospital policy titled “Bylaws of the Medical staff for [Hospital]”, effective 1/27/20212, amendment effective 7/27/20218 indicated the “BASIC RESPONSIBILITIES OF MEDICAL STAFF MEMBERSHIP providing patients with the quality of care meeting the professional standards of the Medical Staff ... abiding by these Bylaws, the Medical Staff Rules and Regulations, the departmental Rules and Regulations, and the Policies and Procedures of the Medical Staff ... complying with all Federal and State statutes ... preparing and completing accurate and complete medical records including electronic records ... updated examination of the patient, including any changes in the patient’s condition, must be completed and documented by a physician ...Therapeutic orders, including electronic written and verbal, may be given by authorized Members of the Medical Staff and allied health staff who are specifically authorized to give orders ... No patient shall be admitted to the Hospital until a provisional diagnosis or valid reason for admission has been stated by the admitting physician ... Each Medical Staff Member must assure timely, adequate, professional care for his patients in the Hospital”. During record review of Patient Care Policy and Procedure for: Women’s and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21”, effective 3/2020, last reviewed 8/2023, stated that “All patients presenting to Labor and Delivery units should undergo an initial period of electronic fetal monitoring ... continuous monitoring will be required to assure appropriate assessment of fetal well-being .... [FHT] validation by a supervising physician ... Examples of High Risk Conditions/Indications for requiring continuous electronic fetal monitoring [measures well-being and fetal heart rate] during labor, [include] Epidural/intrathecal Anesthesia [medication introduced directing into the spine or via a catheter in order to reduce pain and/or movement] ... Meconium [abnormal fetal expelling poop passed into amniotic fluid, a signal of fetal distress] ... Fetal arrhythmia [abnormal FHT] ... Abnormal/Indeterminate fetal assessment testing”. The tables in the policy indicated management of possible FHR patterns: Category I: Routine management. Normal FHR baseline between 110 and 160 bpm with variability (10 to 25 bpm increase or decrease of FHR with sleep, activity and mother’s contractions). Also considered “reassure” fetal well-being. Category II: Absent FHR acceleration (normal increase is 10 - 25 bpm from bassline and maximum HR of less than 160 bpm) and/or absent/minimal FHR variability (Amplitude range undetectable and ? (less or equal to) 5 bpm (heart beat per minute] variability. Tachycardia (fast heart rate) Baseline rate greater than160 bpm. If FHR do not improve consider delivery. Category III FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing do not improve, consider prompt delivery.”

“SUPERVISION OF EMERGENCY SERVICES CFR(s): 482.55(b)(1) The emergency services must be supervised by a qualified member of the medical staff. This Standard is not met as evidenced by: 42125 The emergency services must be supervised by a qualified member of the medical staff ... A qualified member of the medical staff must supervise the provision of emergency services. Since §482.55(a)(1) requires that emergency services must be organized under the direction of a qualified member of the medical staff, the requirement for supervision at§482.55(b)(1) must be distinguished from the prior requirement. In this context, “supervision” implies a more immediate form of oversight by a qualified member of the medical staff during all times the hospital makes emergency services available ... verify that a qualified member of the medical staff is designated to supervise emergency services. Based on observation, interview and record review, in accordance with hospital policies, the emergency department (ED) failed to ensure the presence of a qualified physician obstetrician (OB- care of pregnant mother and fetus) to supervise nurses whom provided emergent medical care to one of one pregnant patient (Pt1). This failure allowed unsupervised RNs to provide emergency medical care to patients and placed the safety and care in jeopardy for all patients entering the OB emergency department (OBED) and Labor and Delivery (L&D) with emergent medical conditions. Findings: Record review of Pt1’s OBED medical care from 3/14/2024 3:38 p.m. to 6:39 p.m. indicate the following: The chart indicate Pt1 spent 86 minutes in the OBED and after being transferred spent another 33 minutes in Labor and Delivery (L&D) without an evaluation by a physician for a medical emergency. On 3/14/2024 at 4:38 p.m., the chart indicated Pt1 arrived at the OBED in “Labor [signs indicating ready to give birth]” and was placed in a room. At 4:45 p.m., the chart indicated a RN (nurse) placed orders for medications, intravenous (I.V.- given via a vein) fluids and monitors, and provided a diagnosis and started to carry out her orders for Pt1. There was no documented evidence, an OBED nurse spoke with a physician. There was no documented evidence a medical screening examination (MSE) by a physician occurred for an emergency medical condition (EMC). At 5:00 p.m., the nurses documented, Pt1 was placed on a fetal heart monitor for (FHT- measures character, pattern and rate of a fetus’ heartbeat. A normal heartbeat fluctuates between110 to 160 that increase and decrease with sleep, activity and contractions and signals fetal well-being). FHT were measured at 140 beats per minute without the normal heart rate fluctuations (a signal of fetal harm and distress). There was no documented evidence a MSE examination or stabilization an EMC was provided by a physician. At 5:05 p.m., chart indicated verbal orders were “authorized” by MD1 and indicated that the OB physician was to be notified for meconium (fetal stool), fetal heart rate abnormalities per policy. There was no documented evidence MD1 spoke with a nurse or examined the Pt1. At 5:09 p.m., chart indicated MD2 ordered I.V. fluids with instructions: “May increase to 500mL bolus [large volume of I.V. fluid given rapidly] for abnormal fetal heart rate patterns”. There was no documented evidence MD2 spoke with a nurse or examined the Pt1. At 5:20 p.m., the nurses documented FHT were measured at 140 bpm without the normal heart rate fluctuations that would signal fetal well-being. Treatment initiated by nurses were I.V. fluid bolus and “therapeutic touch”. At 5:28 p.m., the nurses documented Pt1’s complaints of pain “7/10 [zero to ten pain scale, 0 equals no pain, 10 equals severe]”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluation. At 5:28 p.m., the chart indicated Pt1 had a “high” white count (WBC, high counts are a sign of an infection) of 13.7 (normal 5.5-11). At 5:36 p.m., the nurses documented FHT monitoring strip indicated fetal heart rate 145 bpm with new variable deceleration (abnormal decrease in FHT and a signal of fetal harm and distress) without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence an OBED nurse spoke with a physician or a physician evaluated Pt1. At 5:41 p.m., the chart indicated MD2 signed Pt1’s orders and diagnosis placed by the nurses and MD1. There was no documented evidence, MD1 spoke to the nurses or a physician examined the Pt1. At 5:42 p.m., the nurses documented FHT 145 bpm without the normal heart rate fluctuations that would signal fetal well-being, and thereafter FHT recording stops. There was no documented evidence an OBED nurse spoke with a physician, or a physician examined the Pt1. At 5:56 p.m., the nurses documented Pt1’s complaints of “cramping”, “worsening” and pain “7/10”. Nursing intervention “therapeutic touch”. There was no documented evidence an OBED nurse spoke with a physician or a physician examined the Pt1. At 6:02 p.m. the nurses documented fetal heart rate 145 bpm with continued variable deceleration without the normal heart rate fluctuations that would signal fetal well-being. There was no documented evidence of FHT monitoring strips from 5:42 p.m. onward. There was no documented evidence an OBED nurse spoke with an OB physician. There was no documented evidence an OB physician provided a MSE or stabilization for an EMC prior to Pt1 leaving the OBED. At 6:04 p.m., the chart indicated Pt1 was admitted to Labor and Delivery (L&D) floor and transferred from the OBED. There was no documented evidence Pt1 received a medical exam or medical stabilization by an OB physician on arrival to L&D. At 6:39 p.m., the chart indicated MD2 was called to the bedside. The chart indicated this was the first evaluation of Pt1 by an OB physician. MD2 documented “no fetal heart tones per” and diagnosed “IUFD [intrauterine fetal demise, death of infant before birth]”. During a interview and concurrent record review on 4/25/2024 at 9:00 a.m. with Medical Doctor, Emergency Department Director (MD3) accompanied by Chief Medical Officer and Obstetrician (CMO), and Director of Medical Staff Affairs (DMS), hospital policies were reviewed and discussed, but MD 3 could not see the records due to technology. MD3 stated he was the medical director for the hospital emergency department (ED). MD3 stated there should “always” be a physician in the ED, and there is “never” a case when there is not. MD3 stated the patient is the responsibility of the physician and medical care is provided “as soon as you can”. MD3 stated an EMC, MSE and stabilization of patient is “not done the over the phone” by a physician and “nobody [patient] leaves the department without a face-to-face evaluation”. MD3 stated a pregnant woman in labor who arrive in the OBED or ED, EMTALA requirements still apply. MD3 indicated OB patients can be seen in the main ED and are provided a MSE and stabilization. If the complaint labor or pregnancy related, after triage, the patient is “escorted” by ED staff to the OBED. On the other hand, a pregnant women go directly to the OBED for an EMC, receive an MSE and stabilizing treatment by an OB physician and it’s “not done by phone”. During an interview and concurrent record review on 4/24/2024 at 11:30 am with Medical Doctor (MD), Obstetrician (physician who provides medical care to pregnant mothers and unborn infants), accompanied by CMO and DMS, Patient 1’s (Pt1) medical record provided by the hospital and hospital policies were reviewed and discussed. The Medical Doctor, Obstetrician (MD2), stated she “understands hospital policies ...been at the hospital for twenty years”. MD2 indicated she understood responsibilities of EMTALA (Emergency Medical Treatment Act and Active Labor Act). MD2 indicated that the emergency department for obstetrics (OBED) was a unit that evaluated emergency pregnant patients, determined their acuity, diagnosed medical issues, made a plan of care, managed and stabilized them. MD2 stated a woman in labor (ready to deliver a baby) is considered a “medical emergency condition [EMC]”, and the patient requires a medical screening exam (MSE, evaluation of a emergency medical condition). MD2 indicated RNs were non-physicians; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform surgeries. MD2 stated the patient will be “seen by the nurses [RNs]”. MD2 stated “nurses are “qualified” to complete MSE for an EMC, and provide stabilizing medical treatment and ongoing assessments. MD2 stated if the “RN needs direction, it is given over the phone”. MD2 stated the physician “doesn’t need to see the patient”, and this has been the “standard” for years at the hospital. MD2 stated, without a physician evaluation of a pregnant patient, nurses are allowed to place orders as “verbal orders” for medications, monitors, intravenous fluids, treatments, admission and provide an admitting diagnosis for a patient in the computer. MD2 stated that she “signs 100’s of orders” from the nurses that “pop-up” in her computer “inbox” and one of her “chores” is to e-sign (electronically sign) and approve orders from nurses. MD2 indicated she does not evaluate patients that she signs verbal orders for, nor determine who the orders are for or why they were ordered by the nurse. At 5:09 p.m., the chart indicated MD2 ordered intravenous fluids, MD2 acknowledged that she did not speak to the nurses or evaluate Pt1. The chart indicated MD2 ordered intravenous fluid. MD2 acknowledged at 5:41 p.m., she signed and agreed with the admitting diagnosis and orders, the nurse had placed in the computer as “verbal orders”. MD2 acknowledges she did not call the nurse about the PT1’s status and emergency medical condition, nor ask the nurses about the orders placed or admitting diagnosis. MD2 stated she “doesn’t call the nurses when verbal orders are placed by the nurse ... I sign the orders” for nurses. MD2 stated ongoing fetal (unborn baby) heart tones (FHT, character, pattern and rate of a fetus’ heart) are “important to monitor” and reflect the “well-being of the infant”. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise and require emergency intervention to ensure the life and safety of the fetus and mother. MD2 explained abnormal and changes of FHT could indicate fetal distress and compromise, for example, low to no oxygen delivery or blood flow. MD2 indicated if a fetus expels meconium (fetal stool), it is abnormal and a sign of fetal distress. MD2 acknowledged abnormal FHT tracings that do not improve and “could signal an emergency” for the fetus and/or mother. MD2 indicated OB RNs are “qualified” to interrupt, diagnose and act upon abnormal FHT, but are not physicians. Thus, not qualified to diagnosis, order interventions, or perform emergency procedures and surgeries for pregnant patients. The chart indicate Pt1 spent 85 minutes in the obstetric emergency department (OBED) plus 33 minutes in L&D before being evaluated by a physician for a medical emergency. MD2 acknowledged that on 3/14/2024 she was on call to provide medical services and “responsible” physician for the OB emergency services, MSE, stabilization and ongoing assessments of OB patients, and not the nurses. MD2 stated she was “available” to see Pt1 when she arrived at the emergency department for obstetrics (OBED) at 4:39 p.m. MD2 acknowledged the nurses admitted, provided a diagnosis and wrote orders for Pt1’s. MD2 indicated that the first time she spoke to the nurse about Pt1 was about 30 minutes after she was admitted to L&D. MD2 acknowledged she did not provide medical care or medical oversight to the OBED and L&D nurses for the first 119 minutes Pt1 was in the facility. During a interview and concurrent record review on 4/24/2024 at 4:45 p.m. with Medical Doctor, Obstetrician and Department Director (MD1), accompanied CMO and MRA, Patient 1’s medical record provided by the hospital and hospital policies were discussed and reviewed. MD1 stated he was the Director of the OB department. MD1 stated indicated he understood EMTALA requirements and OB policies. MD1 stated the “concerns” on the OB floors are related to “problems caused by [hospital] management”. MD1 indicated that management “hired nurses” to work on OB floor and the have “zero management oversite” of the care they provided. The nurses “didn’t know how to put on monitors and didn’t know what was going on” with pregnant mothers and fetal status. MD1 explained the “normal process” in the OBED. MD1 stated OB RNs are “QMP [non-physician qualified medical provide; thus, not qualified to diagnosis, prescribe, order interventions, medications and therapeutics or perform emergency procedures and surgeries]” and complete a medical screening exam (MSE), stabilizations and ongoing evaluations for OB and L&D patients. The nurses will “triage [determine level of acuity]” and determine if there is an “emergency”. MD1 stated the “standard for years” at the hospital has allowed the nurses to use their “judgment” to diagnosis, order medications and treatments, and admit to patients in order to “expedite” medical care that may otherwise be “delayed”. After the nurse has provided an MSE, without physician evaluation or communication, the nurses will place orders, as “verbal orders”, for medications, monitors, intravenous fluids, treatments, diagnosis and admit patients. The orders written by the nurses are sent to the physicians “in box” electronically and the physician will sign them up to 2 days later. MD1 stated he receives “100’s of orders [written by nurses] and do not check who they are from ... it is difficult to verify who and what the orders are for ...just sign-off” without review. At some time, the nurses will “talk with the physician” about the patient’s status. MD1 stated continuous FHT monitors “make sure the baby is okay ...ensure fetal well-being ...needs to be maintained throughout [hospital] stay”. MD1 stated he does not agree with the time recommended to intervene for abnormal FHT tracings that last greater than 20 minutes. The hospital policy titled Patient Care Policy and Procedure for: Women’s and Infants Services, Fetal Heart Rate and Uterine Surveillance, Index No. 21” was reviewed with MD1.It indicated management of possible FHR patterns: Category I (CAT1): Routine management. Normal FHR baseline between 110 and 160 bpm (heart beat per minute) with variability (an increase or decrease of 6 to 25 bpm of FHR with sleep, activity and mother’s contractions MD1 stated CAT1 “reassures” fetal well-being. Category II (CAT2): Absent FHR acceleration (normal increase is 6 - 25 bpm from bassline with a maximum HR of 160 bpm) and/or absent or minimal FHR variability (amplitude (height) range undetectable and less or equal to 5 bpm variability. Tachycardia (fast heart rate greater than 160). “ If FHR do not improve consider delivery”. MD1 acknowledged that the CAT 2 tracing could change to CAT 3 emergency tracings. Category III (CAT3): FHR tracings include: Persistent absent baseline FHR variability. Bradycardia (slow FHR, below 110). Sinusoidal pattern (visually apparent, smooth, sine wave-like undulating pattern in FHR baseline) for > 20 minutes. If FHR tracing “do not improve, consider prompt delivery”. The chart indicated for 62 minutes, the fetal heart rate was 140 -145 bpm, with minimal variability and decelerations and after for another 25 minutes FHT could not be located. The FHT record strips from 5:00 p.m. to 5:42 p.m. were reviewed with MD1. MD1 stated the first variable deceleration was at 5:36 p.m., and FHT monitoring records were not available after 5:48 p.m. According to nursing documentation, variable decelerations were still present at 6:02 p.m. After 6:05 p.m., MD1 indicated Pt1 was on the L&D floor and the couple of minutes of FHT tracing strips were not informative and may have been the “mother’s heart rate”. MD1 stated after 5:48 p.m., “something happened” to the baby” and fetal well-being “could not be determined”. MD1 acknowledged that at 5:00 p.m., FHT tracing were abnormal, may have changed to CAT3 and required emergency intervention. MD1 stated he does not agree with policy that a physician should evaluate and intervene if abnormal FHT tracings last greater than 20 minutes. MD1 indicated OB nurses are qualified to interrupt, diagnose and respond to abnormal FHT. MD1 stated if the nursing staff were “not worried” about FHT than “nothing is done”. The records indicated MD1 “authorized” nurse to place orders under his name for Pt1 on 3/14/2024 as early as 5:05 p.m. On 3/14/2024, MD1 stated he did not evaluate Pt1 or discuss Pt1’s status with the nurses. MD1 stated he only evaluated Pt1 on 3/15/2024. MD1 indicated from 3:38 p.m. to 6:39 p.m. OB emergency medical services, MSE, and ongoing evaluations and stabilization of Pt1 and her fetus was provided by nurses, and not physicians. MD1 stated “during root cause analysis (RCA- a process to uncover causes of problems) and interview with the nurses”, they reported “heard FHT”, but there were no FHT strips. MD1 indicated hearing noise does not determine fetal well-being, “it could have been the mother’s” heartbeat. MD1 stated Pt1 was removed from the monitors at 5:48 p.m. and it appeared “the fetus was alive ... but not properly monitored in the OBED after 5:48 p.m. and not on L&D”. The chart indicate Pt1 spent 85 minutes in the OBED plus another 33 minutes in L&D before being evaluated by the OBED on call physician, MD2, for a medical emergency. MD1 stated it took “longer than expected” for Pt1and the fetus to be evaluated by MD2. MD1 stated, even if Pt1 and her fetus had a timely MSE, evaluation and stabilization, it “would not have made a difference in the outcome ...fetal demise would have occurred”. It was “unfortunate”. MD1 stated the “physicians and nurses do a great job ...experienced ... the hospital is not unsafe”. During record review of the hospital policy titled Department of OB-GYN [obstetrics (OB)- care of pregnant women & Gynecology (GYN) women’s reproductive system] /Perinatology, [care of pregnant mothers-woman’s heath/care of fetus, unborn baby], Rules and Regulations”, effective 5/2012, last reviewed 8/2023, stated that “ High risk Ob-Gyn cases will be managed by an individual who has completed a fully approved residency training program in Obstetrics & Gynecology ...Obstetrical Emergency Department (OBED) located in a designated location on the obstetrical unit to be assessed for medical conditions ... The OBED will work to collaborate with the Emergency Department ... EMTALA requirements related to obstetric care should be as follows ... A medical screening examination (MSE) must be performed by an appropriately privileged physician to determine whether the patient has an emergency medical condition, 2. If an emergency medical condition exists, patient must be stabilized and transferred to the labor unit or appropriate acute care hospital department”. During record review of hospital policy titled “[Hospital] Emergency Medical Treatment and Labor Act (EMTALA) Compliance, Index No. A-11” approved July 2023, stated an “Emergency Medical Condition (“EMC”): A medical condition manifesting itself by acute symptoms of sufficient severity ...such that the absence of immediate medical attention could reasonably be expected to result in ...placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy ... serious impairment to bodily functions ... A pregnant woman who is having contractions is considered to have an EMC ... Medical Screening Examination (“MSE”): An examination conducted by a physician or Qualified Medical Personnel ...as documented in the Hospital’s Bylaws, Rules and Regulations or Board Resolution ...To Stabilize or Stabilized: No material deterioration of the EMC is likely”. During record review of hospital policy titled “[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5”, effective June 2014, last reviewed 4/2020, stated that “assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay ...Therapies, procedures and interventions that are conducted in the OBED include, but are not limited to: Recognition, interpretation and recording of patient vital signs and symptoms, particularly those that require immediate notification of a physician [and] Physician Oversight ... Patients in labor will be transferred to the Labor and Delivery unit after an appropriate medical screening examination and stabilization in accordance with EMTALA (Emergency Medical Treatment and Labor Act] regulations”. During record review of hospital policy titled “[Hospital] OB Emergency Services Standardized Procedure, Standardized Procedure: OB Medical Screening Examination index No. G-3”, effective June 2014, last reviewed 1/2022, stated that “ Supervision: The OB ED physician or patient’s primary OB physician will provide supervision... A pregnant individual having contractions is considered to have an emergency medical condition ... ‘Emergency medical condition’ means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the pregnant woman and/or her unborn child in serious jeopardy ... Diagnosis: Physician is to give a diagnosis on all patients receiving a MSE in OBED. During record review of hospital policy titled “[Hospital] Emergency Medical Treatment and Labor Act (EMTALA) Compliance, Index No. A-11” approved July 2023, stated an “Emergency Medical Condition (“EMC”): A medical condition manifesting itself by acute symptoms of sufficient severity ...such that the absence of immediate medical attention could reasonably be expected to result in ...placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy ... serious impairment to bodily functions ... A pregnant woman who is having contractions is considered to have an EMC ... Medical Screening Examination (“MSE”): An examination conducted by a physician or Qualified Medical Personnel ...as documented in the Hospital’s Bylaws, Rules and Regulations or Board Resolution ...To Stabilize or Stabilized: No material deterioration of the EMC is likely”. During record review of hospital policy titled “[Hospital] Policy and Procedure for Women and Infants Services, Scope of Services for the Obstetrical Emergency Department, Index No. G-5”, effective June 2014, last reviewed 4/2020, stated that “assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay ...Therapies, procedures and interventions that are conducted in the OBED include, but are not limited to: Recognition, interpretation and recording of patient vital signs and symptoms, particularly those that require immediate notification of a physician [and] Physician Oversight ... Patients in labor will be transferred to the Labor and Delivery unit after an appropriate medical screening examination and stabilization in accordance with EMTALA (Emergency Medical Treatment and Labor Act] regulations”.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA when: 1. The hospital failed to provide an appropriate medical screening examination (MSE- an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether an emergency medical condition [EMC] exists) for seven of 24 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 8, Patient 10 and Patient 12). (Refer to A2406) Because of the avoidable death of Pt 1’s unborn baby, serious actual harm to Pt 3 and serious potential harm to Pt 2, Pt 4, Pt 8 and Pt 10 related to having an emergency medical condition and an appropriate Medical Screening Exam (MSE) was not conducted an Immediate Jeopardy (IJ) situation was called for CFR 489.24(a) A2406 on 4/12/2024 at 5:45 p.m. with the Director of Quality (QD) Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Chief Medical Officer (CMO) and Emergency Department Director (EDD) and were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable IJ Plan of Removal (Version 5) on 4/18/24 at 9:10 a.m. Education, training, and competencies of staff were validated. The components of the IJ Plan of removal were validated onsite through observations, interviews, and record review. The IJ was removed on 4/18/2024 at 2:45p.m. with the Director of Quality, Chief Executive Officer, Chief Nursing Officer, Chief Medical Officer, Emergency Department Director Manager (EDM 1) and Quality Manager (QM). Following the IJ removal, the facility remained in substantial non-compliance. 2. The hospital failed to ensure an emergency medical condition (EMC) was stabilized prior to discharge for five of 24 Patients (Patient 5, Patient 6, Patient 7, Patient 9 and Patient 11). (Refer A2407) Because of the serious actual harm to Patient 5 and Patient 6 and the potential serious harm to Patient 7 and all patients in Hospital A who had an Emergency Medical Condition (EMC) and not provided stabilizing measures, an Immediate Jeopardy (IJ) situation was called for CFR 489.24(d) A2407 on 4/12/2024 at 5:45 p.m. with the Director of Quality (QD) Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Chief Medical Officer (CMO) and Emergency Department Director (EDD) and were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable IJ Plan of Removal (Version 5) on 4/18/24 at 9:10 a.m. Education, training, and competencies of staff were validated. The components of the IJ Plan of removal were validated onsite through observations, interviews, and record review. The IJ was removed on 4/18/2024 at 2:45p.m. with the Director of Quality, Chief Executive Officer, Chief Nursing Officer, Chief Medical Officer, Emergency Department Director Manager (EDM 1) and Quality Manager (QM). Following the IJ removal, the facility remained in substantial non-compliance. The cumulative effect of these systemic problems resulted in the hospital’s inability to provide the statutory EMTALA requirements and care in a safe setting.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 37529 Based on observation, interview, and record review, the hospital failed to provide an appropriate medical screening examination (MSE- an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether an emergency medical condition [emc] exists) for seven of 24 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 8, Patient 10 and Patient 12) when: 1. Patient (Pt) 1 came to the Obstetric Emergency Department (OB ED) on 3/14/24 with a chief complaint of uterine contractions at 40 weeks gestation. This was Pt 1’s fourth pregnancy and it had been uncomplicated. The OB ED Registered Nurse (QMP) conducted an MSE, which included a cervical exam and fetal monitoring for a period of 42 minutes, and Pt 1 was determined to be in active labor (a known EMC). The OB ED RN failed to analyze the fetal monitor results and recognize the need for intervention, discontinued the fetal monitoring without verifying fetal well-being, transferred Pt 1 out of the OB ED to the labor and delivery unit without contacting Pt 1’s physician and did not communicate the fetal heart rate monitoring results to the receiving L&D RN. These failures resulted in delay of an appropriate MSE for the unborn baby, delay in recognizing an EMC existed for the unborn baby, delay in notifying the physician and directly led to the baby’s avoidable death. 2. Pt 4 came to the Obstetric Emergency Department (OB ED) on 11/10/23 at 6:27 p.m. complaining of uterine contractions at term. Pt 4 was registered and then sent to the waiting room without being triaged and was not assessed or placed on a fetal monitor for over two and a half hours. These failures resulted in a delay in the MSE being performed, and a delay in determining whether or not an emergency medical condition existed for Pt 4 and her unborn baby. 3. Pt 2 was brought to the Emergency Department (ED) on 1/15/24 at 9:40 p.m. by a family member with a chief complaint of suicidal ideation (SI-thinking about or planning suicide), overdosed himself last week and was hitting his head on the floor yesterday (1/14/24). The facility staff failed to document Pt 2 had a MSE or was seen by mental health professional. P 2 was sent to the waiting room to wait once triaged by the RN for one hour with no supervision, was roomed in the blue zone (lowest acuity) and Pt 2 left without being seen after being triaged (two hours and 35 minutes later). This failure resulted in Pt 2 not receiving an appropriate MSE or an assessment by a Mental Health Professional, and placed Pt 2 in danger of self-harm. The hospital failed to determine whether an emergency medical condition existed for Pt 2 and did not initiate measures to ensure Pt 2’s safety. 4. Pt 3 came to the Emergency Department (ED) on 1/6/24 at 11:42 a.m. with a chief complaint of headache times two days and vital signs (VS-clinical measurements, heart rate, temperature, respiration rate, and blood pressure, that indicate the state of a patient’s essential body functions) on arrival were documented as a pulse of 91 beats per minute (bpm; normal range 60-100 bpm), blood pressure of 165/100 millimeters of mercury (mmHg- normal is less than 120/80 mmHg) and pain 10 out of 10 (0-no pain,1 -3 mild pain 4-6 moderate pain 7-10 severe pain). Pt 3’s VS were not reassessed before discharge and Pt 3’s pain was not reassessed after pain medication administration. These failures resulted in Pt 3 being discharged to an unknown location without stabilization and experiencing worsening blood pressure. Pt 3 returned to the ED on 1/6/24 at 7:03 p.m. and was later transferred to a higher level of care with a diagnosis of hydrocephalus (the buildup of fluid in cavities called ventricles deep within the brain). 5. Pt 8 was brought in by ambulance (BIBA) to the Emergency Department (ED) on 2/23/24 at 9:58 a.m. for chief complaint of chest pain. Emergency Medical Services (EMS) indicated Pt 8 had taken two Nitroglycerin medications without relief of symptoms and documented low blood pressure. Upon arrival to the ED, Pt 8 was triaged as an ESI of 2, and EKG and cardiac monitor were not performed within the timeframe for chest pain guidelines. These failures led to a delay of 31 minutes for the EKG to be performed, delay of 41 minutes to provide cardiac monitor support and delayed services and measures meant to stabilize Pt 8’s emergency medical condition (EMC). 6. Patient (Pt) 10 was brought into emergency department by ambulance with chief complaint of chest pain. Pt 10 did not have EKG done within 10 minutes of arrival and did not have pain reassessed in accordance with facility policy. These failures had the potential to result in a delay in identifying the emergency medical condition, delayed medications, treatment, and transfer of Pt 10 to higher level of care. 7. Pt 12 arrived in the Emergency Department (ED) on 4/13/24 at 8:50 p.m. with the chief complaint of “Chest Pain”. Pt 12 did not have pain assessed and vitals completed in accordance with the facility policy. This failure had the potential to result in delay in identifying emergency medical condition and patient being discharged without vitals being stable and pain at an acceptable level. Because of the avoidable death of Pt 1’s unborn baby, serious actual harm to Pt 3 and serious potential harm to Pt 2, Pt 4, Pt 8 and Pt 10 related to having an emergency medical condition and an appropriate Medical Screening Exam (MSE) was not conducted an Immediate Jeopardy (IJ) situation was called for CFR 489.24(a) A2406 on 4/12/2024 at 5:45 p.m. with the Director of Quality (QD) Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Chief Medical Officer (CMO) and Emergency Department Director (EDD) and were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable IJ Plan of Removal (Version 5) on 4/18/24 at 9:10 a.m. Education, training, and competencies of staff were validated. The components of the IJ Plan of removal were validated onsite through observations, interviews, and record review. The IJ was removed on 4/18/2024 at 2:45p.m. with the Director of Quality, Chief Executive Officer, Chief Nursing Officer, Chief Medical Officer, Emergency Department Director Manager (EDM 1) and Quality Manager (QM). Following the IJ removal, the facility remained in substantial non-compliance. Findings: 1.During an interview on 3/28/24 at 3:42 p.m. with Patient (Pt) 1, Pt 1 stated she did not have any complications during her pregnancy. Pt 1 stated her last appointment with her obstetrician was on 3/12/24, which was her due date. Pt 1 stated she was dilated to 3 centimeters (meaning her cervix was dilated; cm- indicates a unit of measurement where 10 cm is fully dilated and ready to give birth). Pt 1 stated she had a non-stress test (NST) scheduled for 3/15/24 but ended up going into labor on 3/14/24. Pt 1 stated she went to the hospital when the contractions got stronger and arrived at approximately 4:30 p.m. Pt 1 stated she went to the fourth floor OB triage (same as OB ED) where she was registered and had her vital signs taken. Pt 1 stated the nurse tried to get the baby’s heartbeat, but was not able to. Pt 1 stated she was taken to the OB triage room to a bed where they hooked her up to the fetal monitor and she could hear the baby’s heartbeat. Pt 1 stated the nurse told her the heart rate was 133 (beats per minute [bpm]). Pt 1 stated she stayed in the triage bed while she waited for a bed in labor and delivery. Pt 1 stated the fetal monitor was disconnected before she was transported to the sixth floor labor and delivery unit. Pt 1 stated when she got to the labor room she requested an epidural, but was told the anesthesiologist was with another patient so Pt 1 went to the restroom and then walked back to bed. Pt 1 stated the nurse had her sit on the edge of the bed to wait for the anesthesiologist and the nurse did not put the fetal monitor on. Pt 1 stated the nurse could not put the monitor on her because her back was arched, so the nurse was in front of her holding the monitor on her abdomen. Pt 1 said she signed the consent, the anesthesiologist put in the epidural and then they laid her back down on the bed and put the fetal monitor on her but could not find the heartbeat. Pt 1 said they brought in a doppler and still could not find it. Pt 1stated the doctor (MD 4) came in and used an ultrasound machine and said there was no heartbeat and no movement. Pt 1 stated a lady put her hands on Pt 1’s stomach and “shook it to get him [the baby] moving,” and another nurse asked about going to the operating room for a c-section. Pt 1 stated the doctor (MD 4) “decided no c-section, let’s let it come naturally.” Pt 1 stated her baby had a heartbeat when she was in triage and questioned why they couldn’t have resuscitated him. Pt 1 stated “they wrote the time of death at 6 p.m. and I asked if they were 100% positive. They said yes, he was gone, and they were going to confirm with another ultrasound. I’m thinking why wait so many hours after to do an ultrasound, why not do a c-section?” During a concurrent interview and record review on 4/9/24 at 3:20 p.m. with Obstetric Emergency Department (OB ED) Registered Nurse (RN 10), Pt 1’s medical record was reviewed. The record indicated Pt 1 was 40 weeks and two days pregnant with her fourth baby. Review of the “Labor and Delivery [L&D] Timeline” indicated Pt 1 came to the OB ED on 3/14/24 at 4:38 p.m. with a chief complaint of contractions which started at 3 a.m. that morning. Pt 1 was moved from the waiting room to a bed in the OB ED at 4:45 p.m. The L&D Timeline indicated at 5 p.m., an external fetal monitor was in place and the fetal heart rate (FHR) was 140 beats per minute (bpm). There was no assessment of the unborn baby’s FHR variability, presence, or absence of accelerations and/or decelerations, or characteristics of uterine contractions. Pt 1’s pain level was 7/10 (meaning on a scale of 1 to 10, pain level was 7, or moderate to severe pain). At 5:02 p.m., a cervical exam indicated Pt 1 was dilated to 6 cm, intact membranes, 70% effaced (effacement- thinning and shortening of the cervix), and the presenting part was at a minus 2 station (The location of the baby’s presenting part [head] is in relationship to the ischial spines of the pelvis). At 5:05 p.m., admission orders were entered into the electronic health record (EHR) by RN 1 as “Telephone orders with readback [when the physician gives orders over the phone to the RN, and the RN reads those orders back to the physician to confirm accuracy].” The orders included intravenous (IV) fluid, lab tests, medications for pain and an order for an epidural. At 6:54 p.m., RN 1 documented a provider notification note for 5:09 p.m. which indicated “Provider in [Operating Room] OR, RN to enter orders.” RN 10 stated there is no documentation in the record indicating RN 1 spoke with the obstetrician (MD 4), or attempted to contact MD 4. RN 10 stated if an RN needed to communicate with a physician who was in the OR, a call could be made into the OR to directly speak with the physician, or to a nurse in the OR. The L&D timeline indicated an IV was placed and a 1000 milliliter (ml) fluid bolus was started. At 5:20 p.m., RN 1’s note indicated Pt 1 was having contractions every 1-5 minutes lasting 60-90 seconds, the FHR was 140 bpm, with absent accelerations and minimal variability. RN 1’s note also indicated Pt 1 requested an epidural and that this request was communicated by RN 1 to the Practice Coordinator (PC 1) in L&D. The timeline indicated at 5:28 p.m., Pt 1’s pain level was 7/10 with Pt 1’s pain goal 6/10. At 5:42 p.m., RN 1’s note indicated the FHR was 145 bpm, minimal variability, absent accelerations, and variable decelerations. Fetal monitoring was discontinued at 5:42 p.m. There was no indication that RN 1 attempted to notify MD 4 of the minimal FHR variability or absent accelerations for the 42 minutes of fetal monitoring, or the variable deceleration. During a concurrent interview and record review on 4/9/24 at 3:55 p.m. with OB ED RN (RN 10), Pt 1’s medical record was reviewed. Review of the L&D timeline indicated Pt 1 was transferred from the OB ED on the fourth floor to labor and delivery on the sixth floor at 6:04 p.m., with report given by RN 1 to L&D RN (RN 2). RN 10 stated there is nothing else documented from 5:42 p.m. until 6:09 p.m. when vital signs were obtained, and no documentation of fetal status after 5:42 p.m. The record indicated a consent form for anesthesia was signed by Pt 1 at 6:10 p.m. and review of the anesthesiologist (MD 5) notes indicated at 6:23 p.m. an epidural catheter was placed and at 6:25 p.m. the epidural medication was started. MD 5’s note indicated Pt 1’s vital signs and FHR were monitored throughout the procedure and remained unchanged. The fetal monitor strips beginning at 6:04 p.m. did not reflect a baseline fetal heart rate. RN 10 stated there was no documentation of an assessment of the FHR after 5:42 p.m., and no assessment by the obstetrician (MD 4) prior to placement of the epidural. RN 10 stated there are times a patient does get an epidural before being seen by an obstetrician if orders for the epidural are obtained by the RN through a telephone order. Review of RN 2’s notes indicated at 6:25 p.m. RN 2 repositioned Pt 1 following epidural placement and attempted unsuccessfully to obtain a FHR. The OB ED on-call physician (MD 4) was notified and was at Pt 1’s bedside at 6:36 p.m.. MD 4 performed a bedside ultrasound and confirmed there was no FHR. Review of MD 4’s OB history and Physical dated 3/14/24 at 6:59 p.m. indicated, “...I was called to the bedside in my role as the OB ED Laborist to assess an urgent issue, the inability to find fetal heart tones. This was the first time I was notified that the patient was admitted for active labor...” A review of MD 4’s OB Vaginal Delivery Note dated 3/15/24 at 12:01 a.m., indicated Pt 1 had delivered a stillborn male infant at 11:33 p.m. on 3/14/24 with a “tight nuchal cord that could not be reduced...There was a large 6 inch clot noted in the cord at the fetal insertion...Intact placenta delivered on 3/14/24 at 11 :36 p.m. Membranes were meconium stained...” During a review of the fetal monitor strip dated 3/14/24 beginning at 5 p.m. and ending at 5:42 p.m., the monitor strip indicated a baseline fetal heart rate of 140-145 bpm, minimal FHR variability, and no FHR accelerations. At 5:36 p.m., the monitor strip indicated a variable deceleration. There were also several instances where the heart rate did not record, at 5:05 p.m. for less than one minute, at 5:09 p.m. for approximately two minutes, at 5:23 p.m. for less than one minute and at 5:29 p.m. for approximately two minutes. The monitor strip stops at 5:42 p.m. and 50 seconds and does not resume until 6:04 p.m. A review of the fetal monitor strip dated 3/14/24 beginning at 6:04 p.m. and ending at approximately 6:16 p.m., indicated between 6:04 p.m. and 6:08 p.m. a baseline FHR could not be determined, and from 6:08 p.m. until 6:16 p.m. there is sporadic recording of a heart rate of 100-110 bpm and there are no corresponding nurses notes to provide an explanation for what is reflected on the monitor strip, and no indication in the record that the maternal pulse was assessed at the same time as the fetal heart rate in order to ensure the fetal heart beat was correctly identified. During an interview on 4/11/24 at 3 p.m. with registered nurse (RN) 1, RN 1 stated she was the OB ED nurse who took care of Pt 1 on 3/14/24. RN 1 stated she did not notify MD 4 that Pt 1 was at the hospital in labor, did not leave a message for MD 4, and did not notify MD 4 regarding the FHR tracing being a category II tracing. RN 1 stated she knew that MD 4 was in the operating room (OR) with a patient and RN 1 stated she did not want to disturb MD 4. RN 1 stated she was aware that if MD 4 was in the OR, she could have called into the OR, called MD 4’s phone and left a message or contacted the PC to go into the OR to speak with MD 4 if she needed to reach her. RN 1 stated instead of doing any of those things, she put orders in for Pt 1 with the intention of contacting MD 4 later. RN 1 stated when the orders were put in, she selected “telephone with readback,” and understands this was not accurate, she did not speak with MD 4 or receive orders from MD 4. RN 1 stated she and another RN moved Pt 1 in the bed down to the elevators. RN 2 met them there and RN 1 and RN 2 both accompanied Pt 1 to a labor and delivery room. RN 1 stated she gave a brief report to RN 2, but did not give a report about the baby’s fetal heart rate tracing. RN 1 stated she should have communicated this to RN 2, and that it was “inappropriate” for her (RN 1) not to have done so. RN 1 stated she did not inform RN 2 or the PC (PC 1) that she had not spoken with MD 4, or that she did not receive telephone orders for admission or for an epidural from MD 4 as she (RN 1) had indicated in the medical record. During an interview on 4/11/24 at 4:25 p.m. with RN 2, RN 2 stated she was the labor and delivery nurse who received Pt 1 from OB ED on 3/14/24. RN 2 stated she was asked by PC 1 if she could take Pt 1 who was being admitted in active labor from OB ED, and although RN 2 already had a patient, she was in early labor, so RN 2 agreed to take Pt 1. RN 2 stated PC 1 told her Pt 1 was going to have an epidural. RN 2 stated she met RN 1 and Pt 1 at the elevator and received report from RN 1. RN 2 stated she was provided a brief report about Pt 1 and was told Pt 1 wanted an epidural. RN 2 stated she did not receive report regarding the status of the baby including the FHR tracing. RN 2 stated she would have expected to be informed if there were any concerns about the baby. RN 2 stated she assumed RN 1 notified the physician and obtained orders from the physician. RN 2 stated the anesthesiologist was getting set up when Pt 1 arrived in L&D. Pt 1 went to the bathroom and came back and sat on the side of the bed for the epidural procedure. RN 2 stated she was positioned at bedside down in front of Pt 1 and held the ultrasound from the fetal monitor up against Pt 1’s abdomen in an attempt to obtain the fetal heart rate while the epidural was being placed. RN 2 stated she did not look at the fetal monitor during the epidural while she held the ultrasound on pt 1’s abdomen and thought at the time she was hearing the fetal heartbeat. RN 2 stated after the epidural was in she repositioned Pt 1 lying down and then attempted to obtain the FHR but did not detect a heartbeat. RN 2 stated she did Leopold’s maneuvers (abdominal palpation used to determine fetal presentation) but did not feel any fetal movement. RN 2 stated she called for assistance and MD 4 was called to the bedside. RN 2 stated MD 4 performed an ultrasound and did not detect a heartbeat. During an interview on 4/16/24 at 10:35 a.m. with the Chief Medical Officer (CMO), the CMO stated in a hospital with in-house obstetrician coverage twenty-four hours a day and the capability for fetal monitoring twenty-four hours a day, an intrapartum fetal death should not occur. During an interview on 4/16/24 at 1:40 p.m. with PC 1, PC 1 stated she was the PC on the day shift in L&D on 3/14/24. PC 1 stated she was notified that Pt 1 was in the OB ED, was in active labor and needed a bed. PC 1 stated she was also contacted by RN 1 to notify her that Pt 1 had requested an epidural, so PC 1 could let the anesthesiologist in L&D know for planning purposes. PC 1 stated that was the extent of the information she was given about Pt 1 and did not know the fetal monitor strip in OB ED indicated a Category II tracing. PC 1 stated she was called after RN 2 could not find a FHR after the epidural was placed. PC 1 stated she did not find out until after the dayshift ended at 7:30 p.m. that RN 1 did not call MD 4 to notify her of Pt 1’s arrival, contractions, cervical exam and results of fetal monitoring, and did not obtain telephone orders from MD 4 for admission and an epidural. PC 1 stated if she was asked for help contacting a physician who was in the OR, she would have done that. PC 1 stated she expected the RN in OB ED to provide report to the L&D RN regarding the well-being of the patient and the baby including a review of the fetal monitor strip, and to have notified the physician and obtained orders for admission and labor prior to transferring the patient to L&D. PC 1 stated fetal well-being should be determined prior to a labor epidural being placed. During an interview on 4/16/24 at 3:20 p.m. with the OB director (OBD), the OBD stated it is her expectation that RN to RN report at transfer includes a review of the fetal monitor strips. The OBD stated an RN should never indicate an order was obtained from a physician by telephone unless it was. The OBD stated MD 4 should have been notified of Pt 1, including the results of the fetal monitoring while she was in the OB ED. The OBD stated fetal well-being should be established prior to the patient receiving an epidural. During a review of the State of California Certificate of Fetal Death issued on 4/8/24, the certificate indicated, “...THIS FETUS- DATE OF EVENT [Fetal Death]: 3/14/2024 HOUR: 1800 [6 p.m.] ...” The Certificate of Fetal Death was signed by MD 4 on 4/2/24. During a review of the policy and procedure (P&P) titled, “STANDARDIZED PROCEDURE: OB MEDICAL SCREENING EXAMINATION,” dated 1/22, the P&P indicated, “...Initiate a Medical Screening Examination (MSE) on pregnant patients of 20 weeks gestation or greater to determine if an Emergency Medical Condition (EMC) related to the pregnancy exists...Notify the physician immediately for any of the following conditions:...Category 2 or 3 Fetal Tracing... All patients will be assessed for: Contractions: resting tone, frequency, duration, and intensity of contractions; Fetal heart rate: baseline, accelerations, decelerations, variability (minimum of a 20-minute strip); Vaginal exam unless contraindicated. Communicate all assessment findings to the physician. Obtain further orders from the doctor i.e. (admit/discharge, or any further testing) ...” During a review of the P&P titled, Scope of Services for the Obstetrical Emergency Department,” dated 4/20, the P&P indicated, “...Patients in labor will be transferred to the L&D unit after an appropriate medical screening examination [MSE] and stabilization in accordance with EMTALA regulations unless presenting with an emergent situation...” During a review of the [Name of Hospital] website accessed 4/12/24 at 6:46 p.m., the website indicated, “As part of our vision to elevate the level of care and service we provide to expectant moms, [Name of hospital] is proud to provide the Central Valley area’s only OB Emergency Department (OBED) that is staffed 24/7, 365 days a year, with Board Certified OB/GYN hospitalists. If you are greater than 20 weeks and have an urgent or emergent pregnancy-related need, take comfort in knowing that you will be seen by one of our OB/GYN hospitalists or your personal OB/GYN - regardless of time, complications, or circumstances.” During a review of the P&P titled, “Care of the Obstetrical Emergency Department [OB ED] Patient,” dated 6/20, the P&P indicated, “...Patients that are 20 weeks gestation or greater that present to the OB ED with obstetrical complaints other than scheduled Inductions/Cesarean sections, may be assessed and observed for no more than four (4) hours in the OB ED...A qualified Obstetrical triage nurse will briefly and accurately evaluate all patients based upon urgency of complaints or time of arrival if equal urgency, including but not limited to chief complaint and clinical status, using the Maternal Fetal Triage Index (MFTI a 5-level system to facilitate the care of pregnant women seeking care in an obstetrical triage unit [priority 1 being the highest acuity and priority 5 being the lowest acuity])...After triage assessment, patients who do not require immediate care shall be assigned to an exam room as soon as possible...Continuous fetal monitoring will be initiated as applicable for pregnancy gestations 24 weeks or greater, and a Non-Stress Test [NST] conducted to evaluate fetal heart rate, variability, presence of periodic and/or episodic patterns, fetal movement and presence of contractions...A complete nursing assessment shall include, but is not limited to maternal physical status, fetal status, labor status, psychosocial needs and patient interview...The primary Physician/On-call Physician/Hospitalist shall be notified after the initial assessment is complete...” During a review of the P&P titled, Scope of Services for the Obstetrical Emergency Department,” dated 4/20, the P&P indicated, “...The OB ED is open for service to Obstetrical patients, physicians and staff twenty-four (24) hours a day, seven (7) days a week. Then OB ED delivers care to pregnant patients of all ages, 20 weeks gestation or greater, who are experiencing uncomplicated emergency and/or remedial problems associated with pregnancy...The [Name of Hospital] OB ED shall fulfill the following responsibilities: a. Assessment, evaluation, management, and treatment, that is appropriate and timely to patients with obstetric conditions. b. Definitive care for those patients not requiring greater in-depth expertise or follow-up care. c. Provision of care that begins in the prehospital setting (provided by EMS), continues in the OB ED, and concludes with responsibility for the patient transferred to the Labor and Delivery [L&D] Unit, another unit, to another physician, or the patient is discharged...The Obstetrical Unit of ED will be covered by Board Certified OB/GYNs to include private physicians and OB Hospitalist program. The Hospitalist group will remain in hospital 24/7 to provide emergency coverage and provide medical care to the uninsured, no established prenatal care patients...Patients are triaged upon arrival, they are seen on the basis of acuity, otherwise they are treated on a first-come, first-served basis...All patients entering the OB ED shall be assessed by an RN...Patients will be classified according to the Maternal Fetal Triage Index...” During a review of the policy and procedure (P&P) titled, Epidural Anesthesia For Labor Patients, Patient Controlled,” dated 12/21, the P&P indicated,”...PURPOSE: To provide guidelines to nursing staff in assisting the anesthesiologist with epidurals for Labor and Delivery, considering care for mother and unborn fetus. POLICY: Continuous epidural anesthesia is administered by a qualified provider as described by the American Society of Anesthesiologists...Candidates for epidural anesthesia will be agreed upon by the anesthesiologist and the obstetrician. PROCEDURE: Pre-Procedure by RN: Apply Fetal Monitor and assess the FHR. Notify the obstetrician and obtain an order of patient request for epidural anesthesia. Notify anesthesiologist assigned to labor and delivery...Assess the fetal heart rate as continuous as possible during the procedure...Monitor fetal heart rate and contractions continuously during epidural infusion...” During a review of the policy and procedure (P&P) titled, “Fetal Heart Rate And Uterine Surveillance,” dated 8/23, the P&P indicated, “... Procedure for External EFM Ultrasound Application- Validate the fetal heart rate by auscultation before placing the transducer. Assess and confirm FHR baseline rate, baseline variability, and FHR pattern characteristics [presence or absence of accelerations and/or decelerations], and interventions as appropriate using the NICHD definitions. Differentiate fetal heart tracing with maternal heart rate upon admission and as clinically indicated. This can be done by checking the mother’s pulse, or briefly with the pulse oximeter.... Include in RN and OB Provider shift handoff communications: Admission FHR and uterine pattern, Current FHR and uterine pattern, and Significant events and interventions in labor...” During a review of the policy and procedure (P&P) titled, “Fetal Heart Rate And Uterine Surveillance,” dated 8/23, the P&P indicated, “...All patients presenting to Labor and Delivery units at viability should undergo an initial period of electronic fetal monitoring for a minimum of 20 minutes or until fetal well-being is assured after the MFTI (maternal fetal triage index) is assigned. Monitoring for longer periods may be continued depending on the clinical circumstances... Documentation regarding assessment of FHR pattern and uterine activity: Use the full description of the FHR tracing per NICHD definitions to include FHR baseline rate, baseline variability, and FHR pattern characteristics (presence or absence of accelerations and/or type of decelerations), and interventions as appropriate. Document the actions taken to maintain a continuous FHR tracing and/or uterine activity tracing. During a review of the policy and procedure (P&P) titled, “Fetal Heart Rate And Uterine Surveillance,” dated 8/23, the P&P indicated, “..Manage the FHR patterns based upon the interpretation of the tracing ... Management algorithm for intrapartum fetal heart rate [FHR] tracing. Category II-evaluation and surveillance. Absent FHR accelerations and Absent/Minimal FHR variability- Initiate intrauterine resuscitation as appropriate for Category II patterns and document interventions...Documentation regarding Indeterminate (Category II) / Abnormal (Category III) FHR Patterns includes duration of the indeterminate/abnormal FHR pattern, clinical context (e.g. tachysystole, maternal hypotension, maternal temperature, bleeding, medications, etc.), specific intrauterine resuscitation measures implemented and the maternal- fetal response, and notification of the OB Provider and the content of the conversation. Examples of Category II FHR tracings include any of the following:...Minimal baseline variability [Minimal variability- Amplitude range is greater than undetectable and less than or equal to 5 bpm] ...” During a review of the policy and procedure (P&P) titled, “Orders Management,” dated 1/2020, the P&P indicated, “...Telephone /Verbal Orders are accepted in limited situations: A. Communication of orders by this method is limited to urgent situations where immediate written or electronic communication is not feasible. B. The appropriate communication type (Telephone or Verbal) is selected. C. The entire order is entered and then read back and confirmed to the ordering Licensed Independent Practitioner [LIP]...” During a review of the professional reference titled, “American College of Obstetricians and Gynecologists Committee Opinion Number 667, Hospital-based Triage of Obstetric Patients,” dated 7/2016 (reaffirmed 2020), the reference indicated, “...An individual or individuals determined qualified as designated by hospital policy must perform an appropriate medical screening examination to determine whether the patient has an emergency medical condition. This determination should take into account the health of the woman and the fetus...” During a review of the professional reference titled, “American Society of Anesthesiologists Statement on Neuraxial Analgesia or Anesthesia in Obstetrics,” dated 10/13/21, the reference indicated, “...Neuraxial analgesia or anesthesia should not be administered until: 1) the patient has been examined by a qualified individual; and 2) a physician with obstetrical privileges to perform operative vaginal or cesarean delivery, who has knowledge of the maternal and fetal status and the progress of labor and who agrees with the initiation of labor analgesia, is readily available to supervise the labor and manage any obstetric complications that may arise. Under circumstances defined by department protocol, qualified personnel may perform the initial pelvic examination. The physician responsible for the patient’s obstetrical care should be informed of her status so that a decision can be made regarding present risk and further management. Neuraxial analgesia for labor and/or vaginal delivery requires that the parturient’ s vital signs and the fetal heart rate be monitored and documented by a qualified individual...” During a review of the professional reference titled, “Practice Guidelines for Obstetric Anesthesia An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology,” dated 2/2016, the reference indicated, “... Conduct a focused history and physical examination before providing anesthesia care. This should include, but is not limited to, a maternal health and anesthetic history, a relevant obstetric history, a baseline blood pressure measurement, and an airway, heart, and lung examination, consistent with the ASA “Practice Advisory for Preanesthesia Evaluation.” A communication system should be in place to encourage early and ongoing contact between obstetric providers, anesthesiologists, and other members of the multidisciplinary team. Fetal heart rate patterns should be monitored by a qualified individual before and after administration of neuraxial analgesia for labor...” During a review of the professional reference titled, “ AHRQ Publication No. 17-0003-18-EF, AHRQ Safety Program for Perinatal Care- Monitoring for Perinatal Safety: Electronic Fetal Monitoring [EFM],” dated 5/17, the reference indicated, “...Key Safety Elements that support the safe use of EFM:...Teamwork Training-Components of Teamwork Training... Situational awareness during use of EFM refers to all staff caring for the patient knowing what the patient’s plan is through briefings and team management, being aware of what is going on and what is likely to happen next, and what resources are available if needed. In the context of EFM, situational awareness is particularly relevant for Category II tracings, where continued surveillance is often required before a definitive course of action can be determined, and staff need to know what resources are available to them should the patient’s status suddenly change...Use of transition communication techniques to ensure a shared mental model of plan of care and perceived risks between shifts or between units...” During a review of the professional reference titled, “ National Library of Medicine StatPearls: Fetal Monitoring,” dated 1/24, the reference indicated, “...During the first two stages of labor, fetal circulation is subject to compression as the fetus changes position and as uterine contractions occur, and this has the potential to lead to hypoxia and/or acidosis, which may induce fetal distress predisposing to poor outcomes. In monitoring the fetal status, clinicians should pay attention to the baseline fetal heart rate (FHR), variability, accelerations, and decelerations. Category II patterns may involve tachycardia, bradycardia, reduced or marked variability, and/or occasional variable or late decelerations. These patterns may indicate a wide range of fetal and maternal disorders and prompt further investigation into the underlying cause and may necessitate maternal or fetal resuscitation. Category II patterns may resolve spontaneously to become category I, at which point no intervention is necessarily warranted. However, closer observation is needed as the pattern may deteriorate to category III...” 2. During an interview on 4/5/24 at 2 p.m. with Pt 4’s family member (FM 4), FM 4 stated Pt 4 was pregnant with her first baby and the due date was 11/10/23. FM 4 stated Pt 4 was having contractions on 11/10/23 and went to the OB ED that evening when the contractions had become stronger and more frequent. FM 4 stated Pt 4 was registered and then sent to a waiting room with other patients. FM 4 stated Pt 4 was scared and alone and the baby’s father was not allowed to be with her. FM 4 stated Pt 4 was left in the waiting room for hours without an explanation and then when she was finally brought into a room to be checked, she (Pt 4) was immediately put back in the waiting room. FM 4 stated Pt 4 was told if she was in severe pain or felt like she needed to push, to pick up the phone and call the nurse. During a concurrent observation and interview on 4/8/24 at 11:05 a.m. with the OB Director (OBD), the OB ED located on the fourth floor of the hospital was observed. The door opened to a small room with three chairs and another door on the other side of the room. One wall had a window that did not open but allowed the staff inside the OB ED to see when someone entered the room. There was a phone on the wall and signage with instructions for anyone coming to the OB ED to use the phone to let the staff know they are there. Just inside the door to the OB ED was a desk where the Patient Access staff meet and register the patient. The Patient Access Staff (PA 2) stated she asks the patient the reason for their visit, the name of their physician, and the patient signs the consent for treatment. The next step is the assessment by the quick look triage (QLT) nurse. If the QLT nurse is busy with another patient then the newly arrived patient would be sent to wait in the waiting room. The OBD stated there is another much larger waiting room available next to the OB ED.. The QLT nurse (RN 3) stated the quick look process included gathering information about the reason for the patient’s visit, assessment of vital signs and patient’s weight, assessment of the fetal heart rate (FHR) with a doppler (a handheld ultrasound transducer used to detect the fetal heartbeat), and assessment of pain. RN 3 stated the QLT nurse is responsible for assigning the Maternal Fetal Triage Index level (MFTI a 5-level system to facilitate the care of pregnant women seeking care in an obstetrical triage unit, priority 1 being the highest acuity and priority 5 being the lowest acuity). The MFTI is used to determine the order in which patients will receive a full evaluation (the Medical Screening Exam-MSE). RN 3 stated after the MFTI is assigned, she (the QLT nurse) walks the patient back to the triage area where the patient will have a fetal monitor on and will receive a full evaluation by the OB ED nurse. There are eight beds in the OB ED and if the beds are occupied and the patient is stable, the patient may be sent to a waiting room until the bed is available. During a concurrent interview and record review on 4/16/24 at 11:20 a.m. with the OB ED nurse (RN 10) and the OB ED Practice Coordinator (PC 2- responsible for the day-to-day operations of the department during their shift), Pt 4’s medical record was reviewed. The “Labor and Delivery Timeline” indicated Pt 4 arrived in the OB ED on 11/10/23 at 6:27 p.m. RN 10 stated there is no documentation other than the time of arrival entered by the patient access/registration staff until 8:39 p.m. when the QLT nurse took Pt 4’s vital signs. In addition to the vital signs documentation, there was a entry by the QLT nurse at 8:39 p.m. which indicated, “Fetal Heart Rate Mode: Doppler,” but there was no FHR documented. PC 2 stated the QLT nurse should have documented the FHR. The timeline indicated Pt 4 was transferred from the waiting room to the OB ED at 9:24 p.m. and at 9:30 p.m. Pt 4 was placed on a fetal monitor which indicated the fetal heart rate was 120-130 beats per minute with moderate variability and Pt 4 was contracting every 2-3 minutes. PC 2 stated she does not have an explanation for why Pt 4 was registered when she arrived but then was sent to the waiting room for hours prior to being seen by the QLT nurse and having a MFTI level assigned. During a concurrent interview and record review on 4/18/24 at 12:05 p.m. with the L&D manager (RNM) 1, Pt 4’s medical record was reviewed. RNM 1 stated she reviewed the record and the staffing and census from 11/10/23, and does not have any information to explain why Pt 4 was not seen by the QLT nurse and assigned a MFTI level after registration prior to being sent to the waiting room. The RNM 1 stated the purpose of the MFTI is to determine the priority in which a patient will have a medical screening examination (MSE) by the OB ED RN, so it is important for the MFTI to be determined as soon as possible after the patient presents to the OB ED, especially if there are multiple patients who arrive at the same time. RNM 1 stated she does not know why Pt 4 was in the waiting room for so long initially, or why Pt 4 was sent back to the waiting room after the vital signs were obtained at 8:39 p.m. RNM 1 stated she would have expected the nurse to check on the patient in the waiting room and to document that in the record. RMN 1 stated the FHR should have been assessed sooner than 8:39 p.m. and should have been documented. Review of the record indicated Pt 4 continued to have regular contractions but was discharged home at 1 a.m. on 11/11/23 with a diagnosis of “false labor,” and upon arriving home, Pt 4’s water broke, and she returned to the OB ED and was admitted. She delivered a baby boy on 11/12/23. During a review of the policy and procedure (P&P) titled, “STANDARDIZED PROCEDURE: OB MEDICAL SCREENING EXAMINATION,” dated 1/22, the P&P indicated, “...Initiate a Medical Screening Examination (MSE) on pregnant patients of 20 weeks gestation or greater to determine if an Emergency Medical Condition (EMC) related to the pregnancy exists...Notify the physician immediately for any of the following conditions:...Category 2 or 3 Fetal Tracing... All patients will be assessed for: Contractions: resting tone, frequency, duration, and intensity of contractions; Fetal heart rate: baseline, accelerations, decelerations, variability (minimum of a 20-minute strip); Vaginal exam unless contraindicated. Communicate all assessment findings to the physician. Obtain further orders from the doctor i.e. (admit/discharge, or any further testing) ...” During a review of the P&P titled, “Care of the Obstetrical Emergency Department [OB ED] Patient,” dated 6/20, the P&P indicated, “...Patients that are 20 weeks gestation or greater that present to the OB ED with obstetrical complaints other than scheduled Inductions/Cesarean sections, may be assessed and observed for no more than four (4) hours in the OB ED...A qualified Obstetrical triage nurse will briefly and accurately evaluate all patients based upon urgency of complaints or time of arrival if equal urgency, including but not limited to chief complaint and clinical status, using the Maternal Fetal Triage Index (MFTI a 5-level system to facilitate the care of pregnant women seeking care in an obstetrical triage unit [priority 1 being the highest acuity and priority 5 being the lowest acuity])...After triage assessment, patients who do not require immediate care shall be assigned to an exam room as soon as possible...Continuous fetal monitoring will be initiated as applicable for pregnancy gestations 24 weeks or greater, and a Non-Stress Test [NST] conducted to evaluate fetal heart rate, variability, presence of periodic and/or episodic patterns, fetal movement and presence of contractions...A complete nursing assessment shall include, but is not limited to maternal physical status, fetal status, labor status, psychosocial needs and patient interview...The primary Physician/On-call Physician/Hospitalist shall be notified after the initial assessment is complete...” During a review of the P&P titled, “Scope of Services for the Obstetrical Emergency Department,” dated 4/20, the P&P indicated, “...The OB ED is open for service to Obstetrical patients, physicians and staff twenty-four (24) hours a day, seven (7) days a week. Then OB ED delivers care to pregnant patients of all ages, 20 weeks gestation or greater, who are experiencing uncomplicated emergency and/or remedial problems associated with pregnancy...The [Name of Hospital] OB ED shall fulfill the following responsibilities: a. Assessment, evaluation, management, and treatment, that is appropriate and timely to patients with obstetric conditions. b. Definitive care for those patients not requiring greater in-depth expertise or follow-up care. c. Provision of care that begins in the prehospital setting (provided by EMS), continues in the OB ED, and concludes with responsibility for the patient transferred to the Labor and Delivery [L&D] Unit, another unit, to another physician, or the patient is discharged...The Obstetrical Unit of ED will be covered by Board Certified OB/GYNs to include private physicians and OB Hospitalist program. The Hospitalist group will remain in hospital 24/7 to provide emergency coverage and provide medical care to the uninsured, no established prenatal care patients...Patients are triaged upon arrival, they are seen on the basis of acuity, otherwise they are treated on a first-come, first-served basis...All patients entering the OB ED shall be assessed by an RN...Patients will be classified according to the Maternal Fetal Triage Index...Patients in labor will be transferred to the L&D unit after an appropriate medical screening examination [MSE] and stabilization in accordance with EMTALA regulations unless presenting with an emergent situation...” During a review of the [Name of Hospital] website accessed 4/12/24 at 6:46 p.m., the website indicated, “As part of our vision to elevate the level of care and service we provide to expectant moms, [Name of hospital] is proud to provide the Central Valley area’s only OB Emergency Department (OBED) that is staffed 24/7, 365 days a year, with Board Certified OB/GYN hospitalists. If you are greater than 20 weeks and have an urgent or emergent pregnancy-related need, take comfort in knowing that you will be seen by one of our OB/GYN hospitalists or your personal OB/GYN - regardless of time, complications, or circumstances.” During a review of the professional reference titled, “American College of Obstetricians and Gynecologists Committee Opinion Number 667, Hospital-based Triage of Obstetric Patients,” dated 7/2016 (reaffirmed 2020), the reference indicated, “...An individual or individuals determined qualified as designated by hospital policy must perform an appropriate medical screening examination to determine whether the patient has an emergency medical condition. This determination should take into account the health of the woman and the fetus...” During a review of the professional reference, AWHONN’s “Maternal Fetal Triage Index,” dated 2/16/18, the reference indicated, “...Obstetric triage is the brief, thorough and systematic maternal and fetal assessment performed when a pregnant woman presents for care, to determine priority for full evaluation. Triage is followed by the complete evaluation of woman and fetus by Qualified Medical Personnel (MD, CNM, NP, or RN who meets requirements) ...Quality Triage Care: 1. No women waiting, untriaged 2. Classify all women’s acuity 3. Implement standardized approach to triage, evaluation, and escalation... AWHONN’s Perinatal Nursing Quality Measure on Triage: The goal is that 100% of pregnant patients presenting to the labor and birth unit with a report of a real or perceived problem or an emergency condition will be triaged within 10 minutes of arrival...” 39589 3. During a review of the ED Log (the hospital’s record of every patient who comes to the ED), dated January 2024, the ED Log indicated Pt 2 was brought in by car to the ED on 1/15/24 at 9:40 p.m. with a chief complaint of “Suicidal” and left without being seen (LWBS-Patient was triaged but was not seen by a provider and did not have a MSE) on 1/16/24 at 12:15 a.m. During a review of Pt 2’s “Patient Care Timeline (PCT)” dated 1/15/24, the PCT indicated, “ ... [9:40 p.m. Patient arrived in the ED ... 9:41 p.m. Arrival Complaint Suicidal Ideation (SI-thinking about or planning suicide), Danger to self/Danger to Others ... General Complaint onset: Yesterday ... ED Triage Notes Overdosed himself last week, SI today, drank bleach water today, saw psychiatrist today and increased his medications, hit head in the floor ... 9:49 p.m. Other Flowsheet Documentation 1. Wish to be Dead (Past 1 Month): Yes 2. Non-Specific Active Suicidal Thoughts (Past 1 Month) Yes 3. Active Suicidal Ideation with any Methods (Not Plan) Without Intent to Act: Yes 4. Active Suicidal Ideation with Some Intent to Act Without Specific Plan (Past 1 Month): Yes 5. Active Suicidal Ideation with Specific Plan and Intent (Past 1 Month): Yes ... Calculated Columbia Suicide Severity Rating Scale (C-SSRS a screening tool consisting of questions to assess the severity and immediacy of suicide risk) Risk Score (Lifetime/Recent): High Risk 6. Suicidal Behavior (Lifetime): Yes, Suicide Assessment: Adult (C-SSRS) ...” During a concurrent interview and record review on 4/10/24 at 3:50 p.m. with Emergency Department Manager (EDM) 1, Pt 2’s “Patient Face Sheet (PFS)” and “PCT” dated 1/15/24 were reviewed. The PFS indicated Pt 2 was a 27-year-old male. EDM 1 stated Pt 2 arrived to the ED on 1/15/24 at 9:40 p.m. via car with a family member for a chief complaint of SI and danger to self and others. EDM 1 stated Pt 2 was triaged at 9:47 p.m. and was assigned an ESI of 2. EDM 1 stated Pt 2’s ED Triage notes indicated, Pt 2 overdosed himself last week, was suicidal today (1/15/24), drank bleach water today (1/15/24), saw psychiatrist today (1/15/24/) and increased his medications, and was hitting his head on the floor. EDM 1 stated Pt 2’s C-SSRS indicated a high risk for suicide. EDM 1 stated 1/15/24 at 9:53 p.m. Pt 2 was roomed in the blue zone (lower acuity) and was the last documented contact with Pt 2. EDM 1 stated Pt 2 did not have an MSE initiated or completed. EDM 1 stated Pt 2 left with his mother and left without being seen after triage. EDM 1 stated on 1/16/24 at 12:12 a.m. a Registered Nurse (RN) spoke with the patients mom who stated, “ ... spoke with mom ... via telephone and states she took Pt 2 home as he was getting “antsy” and did not want to be at the hospital anymore. Pt 2 was in queue to be seen by physician but eloped before being seen. Mom stated son lives at home with her and she will be with him all night, will call EMS or bring pt to hospital via private vehicles if pt wants to come back to be seen. [Patient Coordinator] made aware ...” EDM 1 stated an MSE was not initiated because Pt 2 was waiting to be seen by the physician but the mom chose to leave before being seen. EDM 1 stated she was unaware on why the physician did not see the patient timely. EDM 1 stated she was unable to validate what time Pt 2 left the ED because he had a family member with him. EDM 1 stated the physician should have seen Pt 2. EDM 1 stated Pt 2 was a high risk for suicide and a sitter (Patient Safety Attendant-PSA) should have been assigned to Pt 2 and not allow the patient to leave the hospital. EDM 1 stated Pt 2 should have been put on a 1799 hold (healthcare providers and other licensed staff have the authority to place a patient on a 1799 hold which allows them to remain in an involuntary medical hold for 24 hours while the facility attempts to locate a healthcare provider with the authority to initiate a 5150 hold). EDM 1 stated it was the hospital’s policy to assign a sitter for patients who were high risk for suicide. EDM 1 stated there was no documentation on a sitter being assigned to Pt 2. EDM 1 stated a charge nurse could have assigned a sitter to stay with Pt 2. EDM 1 stated hospital staff should have called the Police Department to request a welfare check on Pt 2. During a review of the facilitys’ policy and procedure titled, “Emergency Department Arrival (Triage), Documentation, and Discharge” dated November 2023, the P&P indicated, “ ... 3. All patients who seek care will be offered a medical screening exam (MSE) by ED provider ...” During a review of the facilitys’ policy and procedure titled, “Behavioral Health” dated November 2023, the P&P indicated, “ ... All patients over the age of thirteen (13) will be screened for suicide risk using the Columbia Suicide Severity Rating Scale (C-SSRS) ... as part of the initial nursing assessment ... screening determines if suicide risk is low, moderate or high ... The estimation of suicide risk determines the clinical intervention. An RN will complete the initial C-SSRS screen ... A 1:1 PSA shall be always with a High-Risk patient, in the room or doorway and able to reach the patient immediately. The PSA will accompany the patient ... Patients identified as High Risk will only be decreased to a lower risk level by the Social Worker and/or Tele-psychiatrist ...” During a review of the professional reference, “...EMERGENCY SEVERITY INDEX-A Triage Tool for Emergency Department Care,” dated 2020, the reference indicated, “...All level-2 patients are still potentially very ill and require rapid initiation of care and evaluation...The triage nurse has determined that it would be unsafe for the patient to remain in the waiting room for any length of time... Patients currently may be stable but may have a condition that can easily deteriorate... Placement in the treatment area is a priority...” 4. During a review of the hospital’s report of returns to the ED within 48 hours (of a previous ED visit) and ED log were reviewed. The report indicated Pt 3 was a 57-year-old male who came to the ED on 1/6/24 at 11:42 a.m. with a chief complaint of “headache” and was discharged on 1/6/24 at 3:30 p.m. to an unknown location. The report indicated Pt 3 returned to the ED on 1/6/24 at 7:03 p.m. with a chief complaint of Altered Mental Status (AMS- a change in mental function that stems from illnesses, disorders and injuries affecting your brain) and was transferred to another hospital on 1/7/24. During a review of Pt 3’s “Patient Care Timeline (PCT)” dated 1/6/24, the PCT indicated, “ ... [11:42 a.m. Patient arrived in ED ... Arrival Complaint Brought in by Ambulance (BIB) Headache ... 11:48 a.m. Glasgow Coma Scale (GCS- objectively describe the extent of impaired consciousness in all types of acute medical and trauma patients) Best Eye Response: Spontaneous Best Verbal Response: Oriented Best Motor Response: Follows Commands Glasgow Coma Scale Score: 15 (13-15 mild 9-12 moderate 3-8 severe) Patient Acuity: 3 ... Vital Signs Heart Rate: 91 BP: 165/100 Pain Score: 10- Worst possible pain ... Pain Type: Acute Pain Location: Head Pain Descriptors: Aching] ...” During a concurrent interview and record review on 4/11/24 at 3:27 p.m. with Emergency Department Manager (EDM ) 2, Pt 3’s “Patient Face Sheet (PFS)” and “PCT” dated 1/6/24 were reviewed. The PFS indicated Pt 3 was a 57-year-old-male. EDM 2 stated Pt 3 arrived to the ED on 1/6/24 at 11:42 a.m. by ambulance. EDM 2 stated Pt 3 was triaged at 11:48 a.m. and was given an ESI level of 3. EDM 2 stated Pt 3’s chief complaint was a headache for two days. EDM 2 stated a MSE was initiated at 12:04 p.m. by ED Physician (MD) 1. EDM 2 stated at 12:05 p.m. MD 1 ordered medications and labs for Pt 3. During a review of Pt 3’s PCT dated 1/6/24, the PCT indicated, “ ... [12:05 p.m. Orders Placed acetaminophen (pain medication) tablet 650 mg ...12:07 p.m. ... levetiracetam (seizure medication) tablet 750 mg ...” During a concurrent interview and record review on 4/11/24 at 3:35 p.m. with Emergency Department Manager (EDM ) 2, Pt 3’s PCT dated 1/6/24 was reviewed EDM 2 stated at 12:09 p.m. MD 1 ordered social services (SS) consult for Pt 3. EDM 2 stated Pt 3 was roomed (room 41) at 12:39 p.m. EDM 2 stated at 12:47 p.m. RN documented, “ ... Patient stating he has a headache and that “something is not right with his head ...”. EDM 2 stated there was no documentation indicating the MD had been notified of the RN’s “subjective findings” (information given from the viewpoint of the patient). EDM 2 stated if the RN obtained subjective information from the patient, the RN should have notified the MD because it was related to Pt 3’s chief complaint of having a headache. EDM 2 stated Pt 3 was administered acetaminophen tablet 650 mg by mouth at 12:54 p.m. but did not complete a pain assessment before the administration. EDM 2 stated a pain reassessment was not done after the pain medication admisntration. EDM 2 stated the expectation for nursing staff was to assess the patients pain and conduct a reassessment after one hour of oral pain medication admisntration. EDM 2 validated there were no other pain assessments completed during Pt 3’s ED visit. EDM 2 stated at 1:18 p.m. Pt 3’s VS were obtained with a blood pressure of 158/106 mmHg. EDM 2 stated these were the last set of VS taken for Pt 3. EDM 2 stated Pt 3 was discharged from the ED at 3:30 p.m. EDM 2 stated VS should have been taken 30 minutes before discharging Pt 3 from the ED (VS were taken 2 hours and 12 minutes before discharge). EDM 2 stated Pt 3’s blood pressure should have been addressed with the physician. EDM 2 stated, “ ... as an RN I would address the blood pressure with the MD. If MD was notified and okay with it, I would make a note. The only note for that encounter was from MD 1 ... MD 1 refilled albuterol prescription and gave him a prescription for levetiracetam ...” During a review of Pt 3’s PCT dated 1/6/24, the PCT indicated, “ ... [12:09 p.m. Pt 3 reevaluated at bedside. Denies Suicidal Ideation (SI-thinking or planning suicide) ... Does not currently meet criteria for a hold. He’s walking, talking, and able to care for himself. Does have history of homelessness and endorses [illicit drug] use so will order social services consult to give [patient] resources] ...” During a concurrent interview and record review on 4/11/24 at 3:45 p.m. with EDM 2, Pt 3’s PCT dated 1/6/24 was reviewed. EDM 2 stated the PCT indicated MD 1 completed Pt 3’s MSE at “ ... 2:04 p.m. Discharge Disposition Selected ED Disposition set to discharge ...” EDM 2 stated at 2:13 p.m. MD 1 reevaluated the patient and documented, “ ...Pt reevaluated at bedside. Case and labs reviewed, informed of seizure diagnosis. Advised to follow up with primary care provider and to take medications as prescribed. [Prescription] for levetiracetam and albuterol inhaler sent electronically to pt’s preferred pharmacy. Strict return precautions were provided, return to ED with any new or worsening symptoms. All questions and concerns were addressed. Pt understand and agree with treatment plan ...” EDM 2 reviewed Pt 3’s EMR and was unable to locate Pt 3’s discharge location. EDM 2 stated the PCT indicated, “ ...3:11 p.m. After Visit Summary (AVS) Printed Discharge Instructions Patient Signature ... 2:14 p.m. Patient Ready to go ... 2:15 p.m. Departure Condition: Stable ... Mobility at Departure: Ambulatory ... Patient Teaching: Discharge Instructions reviewed; Patient verbalized understanding ... 3:17 p.m. ED Quick Updates-Free text: Pt left did not wait for SS ... 3:30 p.m. Patient discharged ...” EDM 2 stated Pt 3 was homeless and there was no discharge location or disposition documented. EDM 2 stated the AVS did not have a PCP for Pt 3 to follow up. During a review of the Patient Care Record (PCR-ambulance record), dated 1/6/24 at 6:33 p.m., the PCR indicated, “ ... Dispatched to corner of [street names] for a 56-year-old Male found by [city police department]. [City police department] reported finding pt walking along the street, stating they made contact with pt who appeared to be altered and recently discharged from ER. PD stated pt was not answering appropriately and requested EMS. Pt found standing unassisted, w/GCSx13, agitated, no obvious distress, no trauma. Pt answering inappropriately to assessment questions. Pt speaking to third person not present and becoming agitated. EMS noted BG of 96. Vitals and pt’s behavior closely monitored, pt remained stable, Report given to RN ...” During a review of Pt 3’s “Emergency Department Note (EDN)” dated 1/6/24 at 11:42 a.m., the EDN indicated, “ ... [56-year-old male with a history of seizures BIBA complaint of constant headache onset 2 days. Associated symptoms include intermittent confusion. Pt states that he’s been experiencing more seizures recently, his last seizure was 2 days ago. Notes that he woke up and had lost urinary incontinence as well during this episode. Not currently taking any medication for his seizures. Endorses [illicit drug] use, last used today Denies [thoughts of suicide] ...12:09 p.m. Pt reevaluated at bedside. Denies [thoughts of suicide] ... Does not currently meet criteria for a hold. He’s walking, talking, and able to care for himself. Does have a history of homeless and endorses [illicit drug] use so will order social services consult to give pt resources ...” During a concurrent interview and record review on 4/11/24 at 3:50 p.m. with EDM 2, Pt 3’s PCT dated 1/6/24 was reviewed. The PCT indicated, “ ... 7:03 p.m. Patient arrived in ED ... Arrival Complaint Altered Mental Status ...” EDM 2 stated Pt 3 was triaged at 7:07 p.m. with an ESI level of 3 and chief complaint of AMS. EDM 2 stated Pt 3’s VS were taken at 7:07 p.m. with a heart rate of 94 bpm and blood pressure of 170/100. The PCT indicated, “Chief Complaints Updated Altered Mental Status (Pt BIBA, per EMS, pt was found by PD walking down the street a few miles away, pt was just discharged from the ER earlier today. Pt GCS 13 ...” During a review of Pt 3’s EDN dated 1/7/24 at 7:03 p.m., the EDN indicated, “ ... Chief Complaint: Altered Mental Status ... 56-year-old-male BIBA due to AMS. Additionally, he is complaining of a [headache]. He is unsure of whether he fell. He endorses using [illicit drugs] yesterday. Denies feeling more confused than usual. Denies [chest pain and shortness of breath]. Denies thoughts of hurting himself or anyone else. Pt was recently discharged from the ED earlier with a seizure diagnosis and medication for [levetiracetam] and albuterol ... Patient ... stable except hypertension ... will obtain [computer tomography (diagnostic imaging procedure that uses a combination of X-rays and computer technology to produce images of the inside of the body)]head ... Pt found to have hydrocephalus on CT head ... Patient to be transferred to [Acute Care Hospital] for [Neurosurgery- surgery performed on the nervous system, especially the brain] ... During a review of the facility’s policy and procedure (P&P) titled, “Emergency Department Arrival (Triage), Documentation, and Discharge,” revised February 2024, the P&P indicated, “ ...Vital Signs ...3. ESI Level 3: Document every 2 hours. If normal vital sign trends or clinically stable (a minimum of 2 sets of vital signs within normal limits) document at least every 4 hours ...6. Developmentally appropriate, pain scale shall be documented along with ongoing vital signs and [as needed]. 7. Abnormal vital signs are to be reassessed with subsequent notification to primary RN or provider 8. Vital Signs to be documented within 30 minutes of discharge ... Discharge Documentation ... Document vitals within 30 minutes of discharge unless otherwise directed by Emergency Department Provider ...” During a review of the facility’s P&P titled, “Pain Management Guidelines,” revised November 2020, the P&P indicated, “ ...Patients are timely assessed/re-assessed for pain ...POLICY: 1. At point of entry to facility, an initial pain assessment will be performed. The Registered Nurse (RN) will evaluate for pain and teach patient to score their pain and/or relief ... The RN will administer analgesia as ordered for the patients assessment and pain level score using age appropriate... assessment ... 6. Reassessment criteria will be used to evaluate and respond to the patients pain. 7. Documented reassessment will include pain ... 8. Pain will be reassessed and documented ...1 hour after oral pain medicine administration ...PROCEDURE: ...1. Assess and reassess pain at regular intervals appropriate for the specific patient including: ...D. Following pain management interventions, once sufficient time has elapsed for the treatment(s) to be effective. E. Prior to discharge ...” 49230 5. During a concurrent interview and record review on 4/11/24 at 11:30 a.m. with the Director of Emergency Department (EDD), Patient (Pt) 8’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visit dated 2/23/24 indicated, Pt 8 was a 73-year male brought into ED on 2/23/24 at 9:58 a.m. via ambulance with compliant of chest pain onset at 6:30 a.m. in the morning, Pt 8 had taken sublingual (under your tongue) Nitroglycerin (medication used for relief from sudden intense chest pain) two tablets at home and blood pressure in 80’s was reported by the Emergency Medical Services (EMS). Pt 8’s past medical history includes coronary disease (disease caused by plaque buildup in the wall of the arteries that supply blood to the heart), AICD (An automated implantable cardioverter defibrillator uses electrical impulses to return your heart rhythm to a normal pattern), status post stent placement (small, metal mesh tube that is placed inside a coronary artery to help keep the artery open), Atrial Fibrillation (An irregular, often rapid heart rate that commonly causes poor blood flow), gastroesophageal reflux disease (GERD - a common condition in which the stomach contents move up into the esophagus) , hyperlipidemia (an elevated level of lipids like cholesterol in blood ), hypertension (high blood pressure), myocardial infarction (heart attack). Pt 8’s initial pain score on 2/23/24 at 10:01 a.m. was 7 on the scale of 0-10, (0 equals no pain and 10 is the worst pain ever). Pt 8 was triaged on 2/232/24 at 10:02 a.m. and was assigned an emergency severity index (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) of 2. Pt 8’s had no vitals documented on arrival to the ED and should have according to EDD. Physician was assigned at 10:06 a.m. Orders were placed on 2/23/24 at 10:19 for medication acetaminophen (medication to treat minor pain and fever) 975 mg, labs that includes CBC and differential (CBC- blood test that measures many different part and features of blood), Basic metabolic panel (test helps to check the body’s fluid balance and levels of electrolytes, and see how well the kidneys are working), Troponin I high sensitivity (Detecting troponin in the blood can help diagnose a heart attack) , Xray and electrocardiogram (EKG - test to record the electrical signals in the heart). Acetaminophen was given at 2/23/24 at 10:23 a.m. EKG was completed on 2/23/24 at 10:31 a.m. (31 minutes after arrival to ED). Patient 8 was placed on a cardiac monitor at 10:40 a.m. (and first set of vitals were completed 41 minutes after arrival to ED) and Pt 8’s vitals indicated Heart rate 64 beats per minutes (bpm - normal 60-80), Respiratory rate 17 breaths per minute (normal 12-20), Blood Pressure 107/68 millimeter of mercury (mmHg - between 90/60 and 120/80). Primary assessment by Registered Nurse (RN) was completed at 10:39 a.m., pain was reassessed at 10:40 a.m. down to pain score of 4. Pt 8’s CBC results on 2/23/24 at 10:40 a.m. indicated Hemoglobin (protein in red blood cells that carries oxygen)13 g/dL (Ref Range: 14-18], Hemotocrit (percentage by volume of red cells in your blood): 39.4 [Ref Range 42-52], Platelets (Platelets are cells that help your blood clot) 140 K/mcl [Ref Range 150-400]. Pt Basic Metabolic Panel results on 2/23/24 at 10:53 a.m. indicated BUN (test can reveal whether urea nitrogen levels are higher than normal, suggesting that kidneys may not be working properly) 28 mg/dL [Reg Range: 8 -21], Creatinine (test to see how well kidneys are performing their job in remove waste from blood) 1.21 mg/dL [Ref Range: .50 - 1.21], BUN/Creatinine Ratio (indicator of kidney health) 23.1 [Ref Range: 10.0-20.0], High Sensitivity Troponin results on 2/23/24 at 10:58 a.m. 14 ng/L (Ref Range: 0-20). Vitals were done on 2/23/24 at 11:32 a.m. Heart rate 63 bpm (normal 60-100), Respirations 20 breaths per minute (normal 12-20), blood pressure 98/62 mm/Hg (between 90/60 and 120/80), no pain documentation with vitals on 2/23/24 at 11:32 a.m. Pt was discharged on 2/23/24 at 11:53 a.m. During a review of the document titled, “ED Physician note”, dated 2/23/24, the ED physician note indicated, “ ... Patient presents with left anterior chest pain and clearly seems to be musculoskeletal/chest wall in nature. Symptoms started at 6:30 in the morning and troponin done more than 4 hours after symptom onset is very normal. Emergency evaluation is unremarkable. [Pt 8] is resting comfortably and clearly safe for discharge and was advised outpatient follow up with primary care. Emergent return precautions given ...” During an interview on 4/11/24 at 11:40 a.m. with the EDD, the EDD stated she had reviewed Pt 8’s medical record for the ED Visit for 2/23/24 and was unable to find any vitals documented during Triage. The EDD stated vitals were most likely done but the team failed to document as the patient arrived with EMS. The EDD stated the record indicated Pt 8 did not have an EKG completed for 31 minutes which was not acceptable for someone who came in with chest pain, with extensive cardiac history including MI and stent placement. The EDD also stated it is not an acceptable practice for patient not to be on cardiac monitor for more than forty minutes. The EDD stated, “Pt 8 arrived with EMS, after taking Nitoglycerin and with EMS reporting blood pressure in 80’s, Pt 8 should have been placed on the monitors as soon as possible after the patient arrived in ER”. The EDD stated Pt 8’s EKG should have been completed and EKG should have had a quick read by provider within the goal of 10 minutes of ED arrival. The EDD stated this was not normal at their facility and unable to comment on why the patient was not on monitors for 41 minutes of ED arrival. The EDD validated no vitals were documented after the 10:40 am vitals and would have expected to see a documented pain assessment with vitals at 11:32 a.m. prior to discharge. The EDD agreed the delay in getting EKG and placing patient on monitors can lead to adverse outcomes for patient and stated ED have protocol for Triage nurse to order EKG as soon as patient arrives in ED with Chest pain. The EDD stated pain policy indicates pain reassessment after one hour of oral medication and Pt 8 received medication on 2/23/24 at 10:23 a.m., reassessment was done at 10:40 a.m. which showed decrease in pain, however, it was not done hour after or at discharge in accordance with the hospital policy. During an interview on 4/11/24 at 2:05 p.m. with the EDMD, the EDMD stated he was the medical director of the ED. The EDMD stated it was a goal for ED team for any patient coming in with chest pain to have their EKG performed and reviewed by provider within 10 minutes to rule out any possibility of ST-elevation myocardial infarction or if the facility need to activate Cath lab as the delay in getting patient affects the prognosis of the patients with ST-segment elevation myocardial infarction. The EDMD stated it was important to avoid any delays in giving patient best chances of survival and minimize any harm to patients. The EDMD stated not aware of patient not being on the monitor for 41 minutes but stated it should not happen with any patient arrival via EMS for chest pain with blood pressure in 80’s. During concurrent interview and record review on 4/11/24 at 11:45 a.m. with the EDD, Pt 8’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the second ED Visit dated 2/23/24 indicated, Pt 8 returned to ED on 2/23/24 at 4:43 p.m. (four hours and fifty minutes after discharge) with chief complaint of chest pain. Pt 8’s Initial vitals on second visit on 2/23/24 at 4:55 p.m. heart rate 62 bpm (normal 60-100), Respirations 16 breaths per minute (normal 12-20), blood pressure 104/64 mm/Hg (normal between 90/60 and 120/80), pain documented on 2/23/24 at 4:57 p.m. indicated pain score of 3 on the scale of 0-10. On 2/23/24 at 4:57 p.m. triage was completed and ESI of 3 was assigned. Pt 8’s vitals on 2/23/24 at 4:57 p.m. indicated heart rate 64 bpm (normal 60-100), respirations 16 (normal 12-20), blood pressure 88/62 (normal between 90/60 and 120/80). Pt 8 had physician assigned at 5:02 p.m. Order was placed for EKG on 2/23/24 at 5:08 p.m. (after 25 minutes of arrival) and performed at 5:09 p.m. The EDD stated EKG order should have been placed in Triage as part of the chest pain protocol. The EDD stated unable to tell when EKG was reviewed by the physician. The EDD stated she was not able to find any notation (physician’s initials and date) on the EKG print out scanned in the medical record. The record for Pt 8 indicated lab for Troponin I high sensitivity and medication order for Ketorolac (medication used to relieve moderately severe pain) injection 15 mg was ordered on 2/23/24 at 5:28 p.m. Pt 8’s pain level assessment on 2/23/24 at 6:56 p.m. indicated Pt 8’s pain level at 6. Pt 8 received Ketorolac injection and aluminum-magnesium hydroxide-simethicone suspension (medication to treat occasional heartburn, indigestion, upset stomach, or other conditions caused by too much stomach acid) on 2/23/24 at 6:56 p.m. No pain reassessment for three hours and fifty minutes after admiration of Ketorolac at 6:56 p.m . The ED physician note at 9:36 p.m. indicated, “ ...patient is hypotensive (BP 85/90) at this time. However, patient has no [sign and symptoms] and states that his [chest pain] is better as well. Given his change in clinical [history]and [overall] medical [history], will admit for observation”. On 2/23/24 at 11:21 p.m. admitting physician was assigned and patient was admitted to inpatient for observation. During a review of the facility’s policy and procedure (P&P) titled, “Emergency Care Services - Index No. C-7),” with a revised date of February, 2024, the P&P indicated, “ ...All patients discharged from the Emergency Department will receive appropriate discharge instructions, including information regarding any necessary follow up care and instructions on medication, devices and diagnosis ...The Nurse will involve other resources deemed necessary to facilitate a safe patient discharge, including ...initiating referral to social worker ...Document vitals within 30 minutes of discharge unless otherwise directed by emergency department provider ...” During a review of the facility’s policy and procedure (P&P) titled, “Pain management guideline,” with a revised date of November 2020, the P&P indicated, “ ...at point of entry to facility, an initial pain assessment will be performed... The RN will administer analgesia as ordered for the patient’s assessment and pain level score using age appropriate and developmental/cognitive function assessment ...Reassessment criterial will be used to evaluate and respond to the patient’s pain ...Document reassessment will include pain and sedation levels ...pain will be reassessed and documented 15 minutes after IV pain medication administration and 1 hour after oral medicine administration ...assess and reassess pain at regular intervals appropriate for the specific patient including: ... Following pain management interventions, once sufficient time has elapsed for the treatment (to be effective) ...prior to discharge ...” During a review of a professional reference retrieved from https://www.ahajournals.org/doi/10.1161/CIR.0000000000001029#d1e1610 , titled, “ 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guidelines for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines, “ the reference indicated, “ The goals in patients presenting to the ED or office with acute chest pain are: 1) identify life-threatening causes; 2) determine clinical stability; and 3) assess need for hospitalization versus safety of outpatient evaluation and management... The 12-lead ECG, which should be acquired and interpreted within 10 minutes of arrival to a medical facility, is pivotal in the evaluation because of its capacity to identify and triage patients with STEMI to urgent coronary reperfusion ... “ 6. During a concurrent interview and record review on 4/11/24 at 1:40 p.m. with the Director of Emergency Department (EDD), Patient (Pt) 10s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician notes” for the ED Visit dated 3/21/24 indicated, Pt 10 was brought into ED by ambulance on 3/21/24 at 5:52 p.m. with a chief complaint of chest pain (CP). Pt 10 arrival documentation indicated a prehospital electrocardiogram (EKG- test to record the electrical signals in the heart): Sinus with abnormal findings. Pt 10’s chief complaint was updated on 3/21/24 at 5:59 p.m. and indicates, “Chest Pain (Chest pain for 5 days with cough, fever, and congestion. Pain reproducible and worsening with cough, deep inspiration, and palpation. [History of] [Stroke - Damage to the brain from interruption of its blood supply] with residuals; [Hypertension] and back pain with methadone - [medication to treat severe pain and narcotic addiction].)” Pt 10’s initial vitals and pain assessment on arrival to ED were completed on 3/21/24 at 6:00 p.m., indicated Pt 10’s heart rate was 96 beats per minute (bpm-normal range is 60- 100 bpm), respirations 16 (breaths per minute normal 12-20 rpm), blood pressure 118/73 millimeter of mercury (mmHg - Unit of measurement) (normal less than 120/80). Pt 10 had pain score of 7 ( pain scale used to rate a person’s pain on a scale of 0 to 10, 0-3 mild pain, 4-6 moderate pain, 7-10 severe pain) Pt 10’s triage was completed on 3/21/24 at 6:02 p.m. and was assigned an emergency severity index (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) of 2. The nurses note on 3/21/24 at 6:04 p.m. indicated, “Pt [brought in by][Emergency medical services - EMS] with CP onset 5 days ago, progressively worsening. Most pain 1700 [5:00 p.m.] today. (+) fever, cough, and nasal congestion. Pt took PM advil 2 [hours] ago. 12 lead had some abnormal findings but no STEMI (ST-Segment Elevation Myocardial Infraction-the most severe type of heart attack). [Glasgow Coma Scale (GCS- is a clinical scale used to reliably measure a person’s level of consciousness, GCS assesses a person based on their ability to perform eye movements, speak, and move their body. A score of 15 means you are fully awake, responsive and have no problems with thinking ability or memory)] score of 15. Hypertensive [when blood pressure in blood vessels is higher, normal blood pressure 120/80 mmHg] in the 140’s but all other [vital signs stable]”. Pt 10 was assigned a provider at 6:07 p.m. on 3/21/24. Physician orders were placed on 3/21/24 at 6:13 p.m. for labs that includes CBC and differential (CBC- CBC- blood test that measures many different parts often used to help screen overall health), Basic metabolic panel (a blood test that measures the body’s fluid balance, levels of electrolytes, and to see how well the kidneys are working), Troponin I high sensitivity (a test to measure a protein that is released during a heart attack), and EKG. A medication order for Pt 10 was placed for ketorolac (medication used to relieve moderately severe pain) injection 15 milligrams (mg) on 3/21/24 at 6:15 p.m. Pt 10’s pain was reassessed on 3/21/24 at 6:16 p.m. and Pt 10 had a pain score of 5. Pt 10’s primary assessment was completed by nurse on 3/21/24 at 6:16 p.m. Pt 10 was administered ketorolac on 3/21/24 at 6:32 p.m. Pt 10 then had an EKG performed on 3/21/24 at 6:46 p.m. (52 minutes after ED arrival time). The EKG report did not have documentation to indicate it was reviewed immediately after it was performed by a physician. The CBC lab resulted on 3/21/24 at 6:47 p.m. indicated Pt 10’s white blood cell count (WBC- normal range 4.5-11) of 19.2 K/mcl (K/mcl - unit of measurement for thousands of cells per microliter of blood) (high WBC most likely indicates infection), Mean platelet value (MPV - test that measures the average size of platelet to get a clear picture of health of the blood cells) 10.3 FL (normal range 7-10), Neutrophils Relative (indicates infection) 87.7 % (normal range 51-70), Neutrophils Absolute (used to check for infection, inflammation, leukemia, and other conditions) 16.85 K/mcl (normal range 2.60-8.20), Hemoglobin (protein in red blood cells that carries oxygen) 12.4 g/dL (normal range 14-18), Hematocrit (percentage by volume of red cells in your blood): 37 (normal range 42-52), Pt 10’s Basic Metabolic Panel results on 3/21/24 at 6:56 p.m. indicated BUN (test can reveal whether kidneys are working properly) 17 mg/dL (normal range: 8 -21), Creatinine (test to see how well kidneys are performing their job in remove waste from blood) 0.60 mg/dL (normal range: .50 - 1.21), BUN/Creatinine Ratio (indicator of kidney health) 28.3 (normal range: 10.0-20.0), Pt 10 vitals were done on 3/21/24 at 7:00 p.m. indicated heart rate 94 bpm (normal range 60-100 bpm), respirations 13 breaths per minute (normal range 12-20), blood pressure 120/73 (normal less than 120/80). On 3/21/24 at 7:01 p.m. Pt 10’s lab results for High Sensitivity Troponin were 14 ng/L (normal range: 0-20). Orders were placed for medications acetaminophen (mild pain medication) and azithromycin (antibiotic medication) on 3/21/24 at 8:35 p.m. The ED physician note on 3/21/24 at 8:40 p.m. indicated, “74-year old male presents to the emergency department for left lower chest pain and [sharp chest pain caused by swelling of the lining of the lungs] has been ongoing for three days. He also reports vomiting yesterday. Otherwise denies any fevers chills diarrhea. Further states he has a productive cough. His labs revealed [high white blood cell count] with [White blood cell count] at 17.4, mild [condition with not having enough red blood cells] [hemoglobin - protein in red blood cells that carries oxygen] at 10.6, [a blood test that measures the body’s fluid balance, levels of electrolytes, and to see how well the kidneys are working] showing mild [low level of sodium, electrolyte abnormality] at 132 without any other abnormalities his respiratory viral panel (test that determines presence of respiratory virus) was negative and troponin was within normal limits patient otherwise had a chest X-ray showing focal consolidation (occurs when the normal, air-filled spaces of the lung are filled with the products of disease) in the left lower lobe concerning for pneumonia (infection of lung) patient was admitted after being antibiotics for treatment for pneumonia.” Pt 10’s pain was reassessed at 8:54 p.m. on 3/21/24 indicating pain score of 6, Pt 10 was given acetaminophen. No pain assessment documented until 8:54 p.m. on 3/21/24 when acetaminophen was given. Pt 10’s disposition was changed to admit to inpatient at 9:17 p.m. on 3/21/24. During the interview on 4/11/24 at 1:50 p.m. with the EDD, the EDD stated an EKG order for Pt 10 should have been placed in triage as part of the chest pain protocol. The EDD stated she was unable to tell when EKG was reviewed by the physician. The EDD stated she was not able to find any notation (physician’s initials and date) on the EKG print out scanned in the medical record. The EDD stated Pt 10’s EKG should have been completed and the EKG should had a quick read by provider within the goal of 10 minutes of ED arrival. The EDD stated it was goal for their team and important to ensure Pt 10 did not have any condition requiring urgent interventions or need to activate cardiac catheterization lab (cath lab -specialized area in the hospital where specialist doctors perform tests and advanced cardiac procedures to diagnose and treat cardiovascular disease) team. The EDD stated pain reassessment was not done in accordance with the facility policy. During an interview on 4/11/24 at 2:05 p.m. with the EDMD, the EDMD stated he was the medical director of the ED. The EDMD stated the goal for the ED was that a patient that came into the ED for chest pain had an EKG performed and reviewed by provider within 10 minutes. The EDMD stated this was done in order to rule out the possibility of ST - segment elevation myocardial infarction (STEMI - the most severe heart attack) or if the facility need to activate Cath lab team. The EDMD stated a delay in cath lab team activation can affect prognosis in patient with ST-segment elevation myocardial infarction (STEMI- the most severe type of heart attack. The EDMD stated it was important to avoid any delays to give patients the best chance of survival. During a review of the facility’s policy and procedure (P&P) titled, “Pain management guideline,” with a revised date of November 2020, the P&P indicated, “ ...at point of entry to facility, an initial pain assessment will be performed... The RN will administer analgesia as ordered for the patient’s assessment and pain level score using age appropriate and developmental/cognitive function assessment ...Reassessment criterial will be used to evaluate and respond to the patient’s pain ...Document reassessment will include pain and sedation levels ...pain will be reassessed and documented 15 minutes after IV pain medication administration and 1 hour after oral medicine administration ...assess and reassess pain at regular intervals appropriate for the specific patient including: ... Following pain management interventions, once sufficient time has elapsed for the treatment (to be effective) ...prior to discharge ...” During a review of a professional reference retrieved from https://www.ahajournals.org/doi/10.1161/CIR.0000000000001029#d1e1610 , titled, “ 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guidelines for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines, “ the reference indicated, “ The goals in patients presenting to the ED or office with acute chest pain are: 1) identify life-threatening causes; 2) determine clinical stability; and 3) assess need for hospitalization versus safety of outpatient evaluation and management... The 12-lead ECG, which should be acquired and interpreted within 10 minutes of arrival to a medical facility, is pivotal in the evaluation because of its capacity to identify and triage patients with STEMI [ST-Segment Elevation Myocardial Infraction-the most severe type of heart attack] ... “ 7. During a concurrent interview and record review on 4/14/24 at 9:15 a.m. with practice coordinator (PC) 3 and the Manger of Quality Department (QM), Patient (Pt) 12’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visit dated 4/13/24 indicated, Pt 12 arrived in the Emergency Department (ED) on 4/13/24 at 8:50 p.m. with the chief complaint of “Chest Pain”. Electrocardiogram (EKG- test to record the electrical signals in the heart) was ordered on 4/13/24 at 8:53 p.m., was performed at 9:04 p.m. and noted as reviewed by the ED physician at 9:05 p.m. Pt 12’s chief complaint was updated to “chest pain (left sided sharp pain since this afternoon)” on 4/13/24 at 9:08 p.m. Triage was competed on 4/13/24 at 9:09 p.m. and Pt 12 was assigned an emergency severity index (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) of 2. Pt 12 had a pain assessment on 4/13/24 at 9:09 p.m. and Pt 12’s pain score was 8 (pain scale used to rate a person’s pain on a scale of 0 to 10, 0-3 mild pain, 4-6 moderate pain, 7-10 severe pain) with acute pain, on left side of chest, sharp and radiating onto the back. Physicians orders were placed on 4/13/24 at 9:18 p.m. for labs that included - Basic Metabolic Panel (BMP- test to check the body’s fluid balance and levels of essential minerals that are vital to key functions in the body), Magnesium (mineral needed to maintain healthy brain and heart function), Troponin I High Sensitivity (a test to measure a protein that is released during heart attack), and Complete blood count with differential (CBC- blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells) and for Chest x-ray (an imagining test that looks at structures and organs in the chest). Pt 12’s initial vitals on arrival to ED were documented on 4/13/26 at 9:26 p.m. (36 minutes after ED arrival). The ED physician notes on 4/13/24 at 10:20 p.m. indicated, “labs unremarkable. EKG without [sudden][abrupt suppression of blood supply as a result of obstruction to heart] [irregular heartbeat]. Troponin within normal limits. Not concern for [acute coronary syndrome - Any condition brought on by a sudden reduction or blockage of blood flow to the heart]. Chest X-ray [ no concerns identified]” Pt 12 was given discharge instructions and after visit summary on 4/14/24 on 12:39 a.m. The ED RN note on 4/14/24 at 12:58 a.m. indicated, “Patient refused last set of vitals, the patient requested registration to cut off wrist band and requested immediate discharge, patient does have taxi voucher” and Pt 12 was discharged on 4/14/24 at 1:41 a.m. Pt 12’s record indicated pain assessment documented only once during the ED visit on 4/13/24 at 9:09 p.m. and vitals were on only done once on 4/13/24 at 9:26 p.m. PC 3 stated unable to locate any other vitals documented or pain assessment documented in the patient medical record for the entire ED visit on 4/13/24. PC 3 stated Pt 12 was assigned ESI of 2 and should had vitals at minimum every two hours. PC 3 stated Pt 12 was in ED for more than four hours and should had pain reassessed and vitals checked prior to discharge. PC 3 stated patient pain score was 8 which is high, and she would have expected reassessment of pain. PC 3 unable to find any documentation if Pt 12’s pain was reassessed or was at acceptable level prior to discharge. During an interview on 4/18/24 at 1:05 p.m. with the EDD, the EDD stated she had reviewed Pt 12’s medical record for the ED visit on 4/13/24. The EDD stated facility policy was to assess vitals for patients with an ESI of 2 every two hours at minimum. The EDD stated she was unable to find pain reassessment after the initial documentation of pain upon arrival to ED on 4/13/24 at 9:09 p.m. and Pt 12’s pain score was 8. The EDD stated she was not able to find any documentation why vitals were not done in accordance with the facility policy prior to discharge. During a review of the facility’s policy and procedure (P&P) titled, “Emergency Care Services - Index No. C-7),” with a revised date of February, 2024, the P&P indicated, “ ...Vital signs ...ESI level 2: Document at least every 2 hours or more frequently based on clinical conditions ...All patients discharged from the Emergency Department will receive appropriate discharge instructions, including information regarding any necessary follow up care and instructions on medication, devices and diagnosis ...The Nurse will involve other resources deemed necessary to facilitate a safe patient discharge, including ...initiating referral to social worker ...Document vitals within 30 minutes of discharge unless otherwise directed by emergency department provider ...” During a review of the facility’s policy and procedure (P&P) titled, “Pain management guideline,” with a revised date of November 2020, the P&P indicated, “ ...at point of entry to facility, an initial pain assessment will be performed... The RN will administer analgesia as ordered for the patient’s assessment and pain level score using age appropriate and developmental/cognitive function assessment ...Reassessment criterial will be used to evaluate and respond to the patient’s pain ...Document reassessment will include pain and sedation levels ...pain will be reassessed and documented 15 minutes after IV pain medication administration and 1 hour after oral medicine administration ...assess and reassess pain at regular intervals appropriate for the specific patient including: ... Following pain management interventions, once sufficient time has elapsed for the treatment (to be effective) ...prior to discharge ...””

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 49230 Based on interview and record review, the hospital failed to ensure an emergency medical condition was stabilized prior to discharge for five of 24 Patients (Patient 5, Patient 6, Patient 7, Patient 9 and Patient 11) when: 1. Pt 5 came to the emergency department (ED) by ambulance on 4/1/24 with a chief complaint of shortness of breath and had missed the prior two dialysis (removal of was and fluid from the body when the kidneys do not work) treatments. Pt 5 did not receive dialysis in the ED and was discharged without any outpatient follow up for dialysis treatment. These failures resulted in Pt 5 experiencing worsening shortness of breath, experiencing hypoxia (a state in which oxygen is not available in adequate amount at the tissue level) and tachypnea (unusal fast breathing) and the need to return to the ED on 4/2/24 at 9:35 a.m. (6 hours and 18 minutes later). 2. Patient (Pt) 6 came to the ED at 9:30 p.m. on 4/4/24 with a chief complaint of “[Shortness of breath] and throat pain”. Pt 6 was not able to swallow his antibiotics due to swelling secondary to peritonsillar abscess (pocket of pus in that collects when tissue becomes infected) and was not assessed for pain prior to discharge. Pt 6 had no primary care physician and was not given follow up instruction for outpatient resources and clinics in accordance with facility’s process. These failures resulted in Pt 6 experiencing worsening pain, worsening difficulty in swallowing, difficulty in managing secretions and returned to Emergency Department (ED) three times before requiring inpatient services. 3. Pt 7 came to the Emergency Department (ED) on 3/28/24 at 8:48 a.m. with a chief complaint of hyperglycemia (high blood sugar) and abdominal pain, excessive thirst, frequent urination, and abdominal pain. Pt 7 received insulin (medication for diabetes) for the first time and was discharged without a blood sugar check prior to discharge. These failures resulted in Pt 7 being discharged without stable blood sugar level. Pt 7 returned to the ED 30 hours and 54 minutes later with blurred vision, increase heart rate and increased blood pressure requiring inpatient admission for diabetic ketoacidosis (DKA-serious complication of diabetes). 4. Pt 11 came to the emergency department (ED) on 4/17/24 with a chief complaint of hyperglycemia (high blood sugar). Pt 11 was sent to ED by the primary care physician (PCP) due to a high blood sugar. Pt 11’s blood sugar on arrival to ED was 351. Pt 11 received fluids and was discharged home without having blood sugar rechecked prior to discharge. Pt 11 was instructed to follow up and care was not arranged prior to discharge. These failures had the potential to result in Pt 11 experiencing worsening hyperglycemia and being discharged with unstable blood glucose. 5. Pt 9 came to the ED on 1/9/24 at 4:31 p.m. with a chief complaint of shortness of breath (SOB) and chest pain for four days. Pt 9 did not have an EKG read by the physician within ten minutes of arrival. Pt 9 was initially given an ESI level of 3 and should have been a 2. Pt 9 had a troponin (indicates heart muscle damage or a heart attack) lab draw on 1/9/24 and did not have a repeat troponin level measured. Pt 9’s vital signs were not reassessed every two hours and did not have stable vital signs before discharge. These failures resulted in Pt 9 having a delay in a MSE and being discharged home without stabilizing an emergency medical condition. Pt 9 returned to the ED on 1/11/24 at 12:50 p.m. and was later admitted to the hospital for an elevated troponin level (a protein that is released into the bloodstream during a heart attack), a thoracentesis procedure (a procedure to remove fluid or air from around the lungs) and continued peritoneal dialysis (PD-a type of dialysis treatment for kidney failure) in the hospital. Because of the serious actual harm to Patient 5 and Patient 6 and the potential serious harm to Patient 7 and all patients in Hospital A who have an EMC and are not provided appropriate stabilizating measures, an Immediate Jeopardy (IJ) situation was called for CFR 489.24(d), A2407 on 4/12/2024 at 5:45 p.m. with the Director of Quality (QD) Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Chief Medical Officer (CMO) and Emergency Department Director (EDD) and were provided the IJ template which documented the immediate actions necessary to address the IJ situation. The hospital submitted an acceptable IJ Plan of Removal (Version 5) on 4/18/24 at 9:10 a.m. Education, training, and competencies of staff were validated. The components of the IJ Plan of removal were validated onsite through observations, interviews, and record review. The IJ was removed on 4/18/2024 at 2:45p.m. with the Director of Quality, Chief Executive Officer, Chief Nursing Officer, Chief Medical Officer, Emergency Department Director Manager (EDM 1) and Quality Manager (QM). Following the IJ removal, the facility remained in substantial non-compliance. Findings: 1.During a concurrent interview and record review on 4/11/24 at 10:00 a.m. with the Director of Emergency Department (EDD), Patient (Pt) 5’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visit dated 4/1/24 indicated, on 4/1/24 at 6:25 p.m. Pt 5 was brought into the facility’s ED by Emergency Medical Services (EMS). Pt 5 had a past medical history of Congestive Heart Failure (CHF- weakened heart condition that causes fluid buildup in the feet, arms, lungs, and other organs), chronic kidney disease (CKD - condition in which the kidneys are damaged and cannot filter blood), on hemodialysis (treatment to filter wastes and water from blood as kidneys do) Monday, Wednesday, and Friday with bilateral below the knee amputation (BKA). Pt 5 missed the prior two hemodialysis treatments before ED arrival on 4/1/24. EMS found Pt 5’s oxygen saturation (vital parameter to define blood oxygen content and oxygen delivery, for adults, the normal range of oxygen saturation is 95 - 100%) at 70% on 5 liters per minute (lpm - unit of measurement) of oxygen. EMS started Pt 5 on non-rebreather mask (a special medical device that helps provide you with oxygen in emergencies) at 15 lpm of oxygen and Pt 5 was brought into ED on 4/1/24 at 6:25 p.m. Pt 5 was triaged at 6:34 p.m. and Emergency Severity Index (ESI - Scoring system used in ED to triage patient to assesses acuity on presentation to the emergency department from most urgent (1) to least urgent (5)) of 1 was assigned. Pt 5 was evaluated by first provider at 6:32 p.m. Pt 5 had a full nursing assessment done at 6: 40 p.m. Orders were placed for Point of care testing (POCT- clinical laboratory testing conducted close to the site of patient care where care or treatment is provided) for electrolyte, lactate (marker of less oxygen to tissue and indicates presence of poor blood flow through the tissue) and venous blood gas (test to determine carbon dioxide and acidity of the blood), comprehensive metabolic panel (CMP- a routine blood test that measures 14 different substances in a sample of blood, to check the body’s fluid balance and levels of essential minerals that are vital to key functions in the body), complete blood count (CBC- blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells) at 6:40 p.m. Results at 6:46 p.m. for POCT lactate: 2.16 [millimoles per liter - scientific unit often used to measure chemicals](normal range:0.5-2), results at 7:08 p.m. for CMP: ...Blood Urea Nitrogen (BUN- amount of urea nitrogen found in blood): 43 mg/dL (Milligrams per deciliter - Unit of measurement) (normal range: 8-21) ... Creatine (measure of how well kidneys are performing their job of filtering waste from blood): 9:04 mg/dL (normal range: 0.50-1.20). Results at 7:22 p.m. for Troponin: 78 ng/l (Nanograms per liter -Unit of measurement) (normal range :0-14). Chest X-ray was completed at 7:23 p.m. and results by radiologist indicate “Correlate for bilateral mid and lower lung fields [infection of lungs with fluids in airways] and [collapse of lung or part of lung]. Asymmetric small volume bilateral [build up of fluid between the tissues that line lungs and the chest] with associated [lung collapse] and consolidations, more on right compared to left.” ED physician note indicated, “ ...this in the setting of missing her [Pt 5] dialysis for 2 days in a row. States she [Pt 5] has no transportation which is why she keeps missing her dialysis and is unable to ambulate due to BKA ...normally on home oxygen at 5 [lpm] at baseline. On examination she has mild crackles but without significant respiratory distress. [Pt 5] was weaned off of her nonrebreather ...tolerating baseline nasal cannula ... [Pt 5] labs all today are chronic findings ...appropriate for discharge with recommended plan to have dialysis scheduled for this morning ...”. ED nursing note, dated 4/2/24 at 2:21 a.m. indicated, “ ...Pt expressed that it is getting late and that her caregiver is only there with her during the day, and she lives home by herself at night ...” The document titled “After visit summary (AVS)”, dated 4/1/24 indicated , “ ...instructions ... you are feeling short of breath because you need to get your dialysis ...Make an appointment to get your dialysis as soon as possible ...you currently have no upcoming appointment scheduled ...you have not been prescribed any medication ...” Pt 5 was discharged on 4/2/24 at 3:09 a.m. (8 hours and 44 minutes later) and sent home via non-emergency transport. During an interview on 4/11/24 at 10:10 a.m. with the EDD, the EDD stated Pt 5’s medical record indicated Pt 5 did not have a primary care physician listed. The EDD stated Pt 5’s medical record indicated her care giver was only there during the day and Pt 5 lives by herself . The EDD stated the patient did not receive any dialysis treatment in the ED and record does not indicate any follow up appointment was scheduled for the patient prior to discharge on 4/2/24 at 3:09 a.m. The EDD stated Pt 5’ with history of BKA, and not having help at night and transportation concerns to hemodialysis she should not have been discharged at 3:09 a.m. The EDD stated in this situation a consult by a nephrologist (medical doctor who specializes in kidney care & diseases) would have been beneficial to the patient. The EDD stated ED has two spaces available to perform dialysis. The EDD stated dialysis would had helped patient with her shortness of breath. The EDD stated Pt 5’s medical record indicated she was not seen by social worker or case manager. The EDD stated adherence to hemodialysis schedule is important to prevent shortness of breath in patient with kidney disease on hemodialysis. The EDD stated the ED team should ensure a patient on hemodialysis should have appropriate resources aligned prior to discharge. During an interview on 4/11/24 at 2:00 p.m. with the MDED, the MDED stated he was the medical director for the ED. The MDED stated he has reviewed Pt 5’s medical record. The MDED stated “Pt 5 would have benefitted from Nephologist consult prior to discharge and potentially would have benefitted from the dialysis in ED.” MDED stated it was important to ensure that a dialysis patient had their appointments and resources aligned prior to discharge. During a concurrent interview and record review on 4/11/24 at 10:15 a.m. with the Director of Emergency Department (EDD), Patient (Pt) 5’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visits dated 4/2/24 indicated Pt 5 was brought back to ED by EMS on 4/2/24 at 9:35 a.m. [6 hour and 18 minutes after discharge] due to shortness of breath and patient was hypoxic (state in which oxygen is not available in sufficient amounts at the tissue level) and tachypneic (condition that refers to rapid breathing), on 5 lpm oxygen vial nasal cannula at home. Pt 5 oxygen saturation was at 70% when EMS arrived and transported patient to ED. Pt 5 triaged was completed on 4/2/24 at 9:51 a.m. and ESI of 2 was assigned. The disposition was selected to admit to inpatient on 4/2/24 at 10:57 a.m. Order was placed for CBC, CMP, Troponin on 4/2/24 at 10:25 a.m. On 4/2/24 at 10:57 a.m. admitting physician was assigned, and order was placed to admit patient to inpatient. Lab results at 11:11 a.m. for BUN 53 mg/dL (normal range 8-21), results for Creatinine 9.78 mg/dL (normal range 0.50-1.20). Results for Troponin on 4/2/24 at 12:11 a.m. shows 117 ng/L (normal range: 0-14). During a review of the facility’s policy and procedure (P&P) titled, “Emergency Care Services - Index No. C-7), with a revised date of February, 2024, the P&P indicated, “ ...All patients discharged from the Emergency Department will receive appropriate discharge instructions, including information regarding any necessary follow up care and instructions on medication, devices and diagnosis ...The Nurse will involve other resources deemed necessary to facilitate a safe patient discharge, including ...initiating referral to social worker ...” 2. During a review of the hospital’s report of returns to Emergency Department (ED) within 48 hours (of a previous ED visit) for April 2024, the report indicated Patient (Pt) 6 was a 25-year-old male who came to the ED at 9:30 p.m. on 4/4/24 with a chief complaint of “[Shortness of breath] and throat pain” and was discharged on 4/5/24 at 3:22 a.m. The report indicated that Pt 6 had returned to the ED on 4/6/24 at 10:24 a.m. with a chief complaint of “Throat pain” and was discharged on 4/6/24 at 11:36. The report indicated Pt 6 returned to the ED third time on 4/7/24 at 5:06 p.m. with a chief complaint of “[shortness of breath] sore throat” and was admitted to the hospital. During a concurrent interview and record review on 4/11/24 at 11:50 a.m. with the Director of Emergency Department (EDD), Pt 6’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visit dated 4/4/24 indicated, Pt 6 was a 25-year-old male, with no primary care physician (PCP), arrived in facility’s emergency department (ED) on 4/4/24 at 9:30 p.m. with chief complaint of “shortness of breath.” Pt 6’s initial vitals on arrival to the ED on 4/4/24 at 9:36 a.m. indicated Heart rate 102 beats per minute (bpm) (normal 60-100 beats per minute), blood pressure 149/88 millimeter of mercury (mmHg - unit of measurement for pressure normal less than 120/80), respirations 16 breaths per minute (normal 12-20). Pt 6 was triaged on 4/4/24 at 10:19 p.m., Pt 6 was assigned an emergency severity index (ESI) level 3 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) and Pt 6’s chief complaint was updated at 10:19 p.m. to, “Throat pain (Noticed abscess on his tonsils (lymph nodes in the back of the mouth and top of the throat). [Y]esterday morning, pain with swallowing. [History]of Peritonsillar abscess (a common infection of the head and neck region) 01/2024)”. Pt 6 had a pain assessment done at 10:20 p.m. and had pain score of 5 (pain scale used to rate a person’s pain on a scale of 0 to 10, 0-3 mild pain, 4-6 moderate pain, 7-10 severe pain). Pt 6 had a physician assigned on 4/4/24 at 10:56 p.m. and orders were placed for medication used to treat swelling, penicillin G benzathine IM (medication used to treat bacterial infection), labs- CBC (blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells) and differential, Basic metabolic panel (BMP-- test to check the body’s fluid balance and levels of essential minerals that are vital to key functions in the body), and CT neck soft tissue w Contrast (diagnostic imaging study that combines the use of a high-tech rotating X-ray machine, a contrast dye, and sophisticated computer analysis to produce high-resolution 3D images of the soft tissues in your neck region from the base of your skull to the top of the chest). Pt 6 received medication used to treat swelling on 4/5/24 at 12:01 a.m., and penicillin G benzathine at 12:07 a.m. The CBC results on 4/5/24 at 12:15 a.m. indicated WBC (high WBC indicates most likely infection) 15.8 K/mcl (K/mcl - unit of measurement for thousands of cells per microliter of blood) (normal range 4.5-11), MCV (measures the average size of your red blood cells , helps provider diagnose certain conditions) 95.3 FL (normal range 80-94), MPV (measures the average size of your platelets, help diagnose certain blood disorder) 10.9 FL (normal range 7-10), Neutrophils Relative (indicates infection) 78.8 % ( normal range 51-70), Neutrophils Absolute (used to check for infection, inflammation, leukemia, and other conditions) 12.42 K/mcl (normal range 2.60-8.20), Monocytes Absolute (high level indicates body is fighting infection) 1.16 K/mcl (0.10-1.00). Pt 6’s had vital signs and pain reassessment done on 4/5/24 at 12:16 a.m. and pain score remained at 5. Pt 6’s BMP results on 4/5/24 at 12:37 a.m. indicated potassium 3.3 millimoles per liter (mmol/L - Unit of measurement -normal range 3.5-5.5). Pt 6’s CT Neck soft tissue with contrast done on 4/5/24 at 1:12 a.m. Pt 6 was given medication use to numb and relieve pain during procedure on 4/5/24 at 2:35 a.m. and peritonsillar drainage done by ED physician at 2:39 a.m. Pt 6 was given discharge instructions on 4/5/24 at 2:46 a.m. The discharge after visit summary (AVS) on 4/5/24 at 2:46 a.m. indicated, “ ...Start taking: Amoxicillin -clavulantate [antibiotic use to treat infections caused by bacteria] ...Pick up these medication at ...schedule appointment with “No Pcp physicians” as soon as possible for a visit in 1 week (around 4/12/24) ...”. Pt 6’s vitals on 4/5/24 at 2:59 a.m. indicated heart rate 92 bpm (normal 60-100), respiration 19 breaths per minute (normal 12-20 breaths per minute), Blood pressure 123/73 mmHg (normal less than 120/80). The RN note on 4/5/24 at 3:02 a.m. indicated, “Pt asking for pain meds prior to discharge. [name of doctor] informed through secure chat. Waiting for response”. Pt 6 had a pain assessment on 4/5/24 at 3:04 a.m. and Pt 6 had a pain score of 5. Pt 6 was given Hydrocodone -acetaminophen 5-325 1 tablet on 4/5/24 at 3:20 a.m. and Pt 6 was discharged at 3:22 a.m. (2 minutes later) with family. During a review of Pt 6’s “ED physician note,” for service date of 4/4/24, the ED physician note indicated, “ ...Primary care physician: No Pcp Physician ...25 [year old] male with [history] of [Diabetes Mellitus] presents to ED [complaint of] throat soreness, onset yesterday ...due to Throat pain (Noticed abscess on his tonsil yesterday morning, pain with swallowing. History of Peritonsillar abscess 01/20240) ...CT Neck Soft Tissue w Contrast Final Result Small area of abscess or phlegmon with in the right palatine tonsil [tissue at the entrance of Respiratory tract in the back of throat] ...Procedures Incision and Drainage [procedure to release pus] ...Peritonsillar Abscess Drainage ...Findings: 2 ml of [pus ] material was aspirated with reduction in size of the abscess ...case reviewed with Pt at bedside ...Pt informed of need for follow up with PCP. Questions and concerns were addressed at this time ...Will [discharge] home ...plan ...Discharge ...No Pcp Physician ...schedule an appointment as soon as possible for a visit in 1 week if symptoms worsens ...” During an interview on 4/11/24 at 1155 with the EDD, the EDD stated, she had reviewed Pt 6’s medical record. The EDD stated Pt 6’s pain reassessment was not done in accordance with facility’s policy. The EDD stated Pt 6 received a pain medication and was discharged without pain reassessment. The EDD stated Pt 6 did not have primary care physician listed in his medical record and there was no indication that reflect Pt 6 received list of clinics for follow up care. The EDD stated Pt 6 should have received list of clinics for follow up care as part of the ED discharge process. During an interview on 4/11/24 at 2:30 p.m. with the EDMD, the EDMD stated he was the medical director for ED. The EDMD stated he had reviewed Pt 6’s medical record with the EDD. The EDMD stated abscess drainage was standard procedure. The EDMD stated he identified opportunities for improvement with provider’s documentation in care for Pt 6. During a concurrent interview and record review on 4/11/24 at 11:57 a.m. with the Director of Emergency Department (EDD), Pt 6’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visit dated 4/6/24 indicated, Pt 6 returned to ED on 4/6/24 at 10:24 a.m. (31 hours and 2 minutes after discharge) with the chief complaint of “throat pain”. Pt 6’s vital on 4/6/24 at 10:27 a.m. indicated heart rate 95 bpm (normal 60-100 bpm), respirations 17 breaths per minute (normal 12-20), blood pressure 128/84 mmHg (normal less than 120/80). Pt 6’s pain assessment was done on 4/6/24 at 10:30 a.m. and Pt 6’s pain score was at 7. Pt 6 triage was completed on 4/6/24 at 10:30 a.m., ESI of 2 was assigned and Pt 6’s chief complaint was updated. The Pt 6 updated chief complaint indicated, “Throat pain (Pt c/o throat pain and states he has abscess to right tonsil dx here in ER 2 days ago. Pt states he is back due to the abscess worsening. Pt is on [antibiotics by mouth] but can only take once a day instead of prescribed twice a day due to increased throat swelling at night. Pt states it is hard to manage his secretions)”. Pt 6 was given benzocaine (to numb the lining of the mouth and throat) spray in mouth/throat on 4/6/24 at 11:00 a.m. The Pt 6’s pain assessment on 4/6/24 at 11:00 a.m. indicated pain score of 7. Pt 6 was given lidocaine (medication that prevents and treats pain caused by some procedures) on 4/6/24 at 11:01 a.m. Pt 6 had peritonsillar abscess drainage performed on 4/6/24 at 11:12 a.m. and culture was sent to lab. Pt 6 was provided discharge instructions on 4/6/24 at 11:28. Pt 6 was discharged on 4/6/24 at 11:36 a.m. During a review of Pt 6’s after visit summary (AVS) dated 4/6/24, the AVS indicated, “ ...follow up with your primary care doctor ... currently have no upcoming appointments scheduled.” During a review of Pt 6’s “ED physician note,” for service date of 4/6/24, the ED physician note indicated, “ ... Primary care physician: No Pcp Physician ...25-year-old male presents to the ED with an abscess, onset 4 days ago. Pt was seen 2 days ago in the ED... Pt states the pain has worsened since he was last seen, and he has not been able to his medications due to swelling ...Right sided peritonsillar swelling, uvala is deviated to the left, consistent with the right sided peritonsillar abscess ...Incision and Drainage ...Peritonsillar Abscess Drainage ...indications: Fluctuant Peritonsillar abscess ...Findings ...4 ml of purulent material was aspirated with reduction in size of the abscess ...complications: none ...Pt informed of peritonsillar abscess diagnosis and need for follow up with PCP ...Questions and concerns were addressed at this time. Will d/c home. Pt understands and agrees to the treatment plan ...Plan ...discharge ...follow up with your primary care [physician] ...” During an interview with the EDD on 4/11/24 at 12:00 p.m. with the EDD, the EDD stated she had reviewed Pt 6’s chart for the ED visit for 4/6/24. The EDD stated she was unable to find any documentation during the second ED visit on 4/6/24 that Pt 6 received resources and list of clinics for follow up care. The EDD stated Pt 6 did not have PCP listed and should have received a list of clinic and resources to establish follow up care after discharge. The EDD also stated she was not able to find any documentation regarding Pt 6’s ability to swallow oral antibiotics and no indication a pain assessment was completed before discharge. The EDD stated Pt 6 was not compliant with antibiotics due to difficulty swallowing and had difficulty in managing secretions. The EDD stated although ED physician had documented reduction in size of Pt 6’s abscess, she did not know if Pt 6 would be able to continue oral antibiotics or manage his secretions. The EDD stated Pt 6 had pain of 7 at 11:01 a.m. on 4/6/24 and had a peritonsillar abscess drainage performed by an ED physician at 11:12 a.m. Pt 6’s vital signs were checked on 4/6/24 at 11:35 a.m. and Pt 6 was discharged at 11:36 a.m. The EDD stated no pain assessment was documented with vital signs at 11:35 a.m. During a concurrent interview and record review on 4/11/24 at 12:07 p.m. with the EDD, Pt 6’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visit dated 4/7/24 indicated, Pt 6 returned to ED on 4/7/24 at 5:06 p.m. (29.5 hours after discharge) with the chief complaint of “shortness of breath, sore throat”. Pt 6 had physician assigned at 5:09 p.m. Pt 6’s vitals on arrival to ED on 4/7/27 at 5:13 p.m. indicated heart rate 99 bpm (normal 60-100 bpm), respirations 18 breaths per minute (normal 12-20), blood pressure 144/92 mmHg (normal less than 120/80). On 4/7/24 at 5:14 p.m. triage was completed, Pt 6 was assigned an ESI of 3, and chief complaint was updated, “Throat Abscess (Patient here yesterday for peritonsillar abscess, and had it drained. [compliant of] continued throat pain and swelling. Difficulty swallowing.)”. Orders were placed on 4/7/24 at 5:24 p.m. for labs, IV (administered into a vein) antibiotics and blood culture (test of blood to check presence of bacteria and other microorganism in the blood). On 4/7/24 at 5:53 p.m. Pt 6 was admitted to in patient. During a review of Pt 6’s “ED physician note,” for service date of 4/7/24, the ED physician note indicated, “ ...25 [year old] male with [history of] [Diabetes Mellitus] and peritonsillar abscess presents to the ED with [compliant of] a throat abscess with associated pain and swelling onset five days ago. Additional symptoms include difficulty swallowing, talking, and breathing ...The patient was here in the ED yesterday when had the abscess drained, and three days ago when the was given antibiotics, which he states he has not been taking since he has been having trouble swallowing. He states his symptoms are continuing to get worse. Of note, the patient does not have an ENT specialist .... Procedures Incision and Drainage ... The patient was seated with the head slightly extended and supported by the head rest. The Topical anesthetic was introduced over the area of greatest fluctuance on the Left/Right ...Findings: X ml of purulent material was aspirated with reduction in size of abscess. Estimated blood loss: X ml ...” During an interview on 4/11/24 at 12:10 p.m. with the EDD, the EDD stated she had reviewed Pt 6’s chart for the ED visit for 4/7/24. The EDD stated the ED physician note about an incision and drainage appears to be a template and was not updated with Pt 6’s procedure findings by the provider. The EDD stated Pt 6 had no primary care physician and was seen three times in the ED, Pt 6 was admitted on his third visit. The EDD stated Pt 6 expressed that he was unable to swallow antibiotics due to swelling and pain and would have benefitted from swallow assessment prior to discharge on the second visit. The EDD stated although the physician note states Pt 6 was stable to discharge, the documentation does not reflect Pt 6’s ability to swallow the antibiotics was assessed prior to discharge. During a review of the facility’s policy and procedure (P&P) titled, “Emergency Care Services - Index No. C-7),” with a revised date of February, 2024, the P&P indicated, “ ...All patients discharged from the Emergency Department will receive appropriate discharge instructions, including information regarding any necessary follow up care and instructions on medication, devices and diagnosis ...The Nurse will involve other resources deemed necessary to facilitate a safe patient discharge, including ...initiating referral to social worker ...Document vitals within 30 minutes of discharge unless otherwise directed by emergency department provider ...” During a review of the facility’s policy and procedure (P&P) titled, “Pain management guideline,” with a revised date of November, 2020, the P&P indicated, “ ...at point of entry to facility, an initial pain assessment will be performed. .. The RN will administer analgesia as ordered for the patient’s assessment and pain level score using age appropriate and developmental/cognitive function assessment ...Reassessment criterial will be used to evaluate and respond to the patient’s pain ...Document reassessment will include pain and sedation levels ...pain will be reassessed and documented 15 minutes after IV pain medication administration and 1 hour after oral medicine administration ...assess and reassess pain at regular intervals appropriate for the specific patient including: ... Following pain management interventions, once sufficient time has elapsed for the treatment (to be effective) ...prior to discharge ...” 3. During a review of the hospital’s report of returns to Emergency Department (ED) within 48 hours (of a previous ED visit) for March 2024, the report indicated Pt 7 was a 31-year-old man who came to the ED at 8:48 a.m. on 3/28/24 with a chief complaint of “high blood sugar and abdominal pain” and was discharged on 3/28/24 at 12:18 p.m. The report indicated that Pt 7 had returned to the ED on 3/29/24 at 9:12 p.m. with a chief complaint of “DKA - serious complication of diabetes that can be life threatening , blurred vision.” During a concurrent interview and record review on 4/11/24 at 11:00 a.m. with the Director of Emergency Department (EDD), Pt 7’s medical record was reviewed. The document titled “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visit dated 3/28/24 indicated Pt 7 was a 31-year-old male who came to the ED on 3/28/24 at 8:48 a.m. with a chief complaint of “Abdominal pain and high sugar, [Pt 7] stated he was told he had Diabetes and not on any medication”. Pt 7’s vital signs on arrival to ED on 3/28/24 at 8:54 a.m. indicated, pulse 88 beats per minute (bpm-normal 60-100 bpm), respiratory rate 16 breaths per minutes (normal 12-20), blood pressure 129/83 millimeters of mercury (mmHg)(normal- less than 120/80 mmHg). Pt 7 was triaged at 8:55 a.m. on 3/28/24. Pt 7 was assigned an emergency severity index (ESI) level 3 (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious). Pt 7’s primary assessment was completed by a nurse at 8:56 a.m. On 3/28/24. Pt 7 was assigned a physician at 9:04 a.m. Lab orders were placed for urinalysis with microscopic reflex culture (test accessing the chemical constituents of urine and detect the presence of abnormal urine cells), magnesium (blood test measures the amount of magnesium in a sample of blood), lipase (test for lipase level in blood, help diagnose disease of pancreas), comprehensive metabolic panel (CMP - a routine blood test that measures 14 different substances in a sample of blood, test to check the body’s fluid balance and levels of essential minerals that are vital to key functions in the body), CBC (CBC- blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells) and differential at 9:20 a.m. The lab results on 3/28/24 on 9:43 a.m. indicated glucose 289 mg/dL (normal range: 70-105), CO2 (test to determine healthcare providers determine if the body is balancing electrolytes properly): 15 mmol/L (normal range: 21-31). Pt 7’s urinalysis results on 3/28/24 at 10:12 a.m. indicated abnormal results significant for urinary tract infection (UTI - infection in any part of the urinary system that includes the kidneys, ureters, bladder, and urethra). Pt 7 received IV (liquids injected into a person’s vein) Lactated Ringer bolus (fluid used to replace water and electrolyte loss in patients) 1000 ml, received insulin (medication used to regulate blood sugar) subcutaneous (under the skin) injection and cefdinir (antibiotic used to treat bacterial infections) 300 mg capsule on 3/28/24 at 10:13 a.m. Pt 7 received IV ondansetron (medication to prevent nausea and vomiting) on 3/28/24 at 10:27 a.m. Pt 7 vitals were assessed at 12:09 p.m. The EDD stated the only blood glucose check was the initial one on 3/28/24 at 9:43 a.m. The EDD stated there was not a recheck of Pt 7’s blood glucose documented after the insulin and fluid administration. The EDD stated Pt 7’s blood glucose was not checked prior to discharge. Pt 7 was discharged at 12:18 p.m. with the diagnosis of hyperglycemia due to poorly controlled diabetes, UTI, uncontrolled hypertension (high blood pressure). The ED physician note, dated 3/28/24, indicated, “ ... 31-year-old male with a history of [diabetes] not taking medications presents to the ED with [abnormally large production or passage of urine] and [excessive thirst] onset 1 week ago ...urinating about 4 times through out night. Also endorses abdominal pain described as cramping. Associated with [Nausea/vomiting] ...Patient reports has not been taking any medications regularly. He does not have PCP established ...Pt informed [Urinalysis] is significant for UTI. Informed the diagnosis of hyperglycemia due to poorly controlled diabetes. Prescription for cefdinir (antibiotic medication), [ondansetron-medication for nausea and vomiting] , and [glucophage](medication to control high blood sugar) sent to Pt 7’s pharmacy. Advised to follow up with PCP for chronic management of diabetes. List of clinics provided in discharge paperwork ....” During an interview on 4/11/24 at 11:15 a.m. with the EDD, the EDD stated it was a standard of care to have blood glucose test done prior to discharge for a diabetic patient and especially after insulin administration. The EDD stated vital signs and blood glucose test are to be documented prior to discharge. The EDD stated without a blood glucose value for Pt 7 there is not a way to determine if blood glucose levels were stable enough for discharge. The EDD stated Pt 7 medical record indicates he was not on any medication for diabetes and received insulin for the first time in ED. The EDD stated insulin medication education was not documented in Pt 7’s chart. During an interview on 4/11/24 at 2:15 p.m. with the MDED, the MD ED stated he was the medical director for the ED. MDED stated it was his expectation that point of care testing (POCT- clinical laboratory testing conducted close to the site of patient care where care or treatment is provided with rapid test results) for blood glucose to be completed after insulin administration and prior to discharge. During a concurrent interview and record review on 4/11/24 at 11:15 a.m. with the Director of Emergency Department (EDD), Pt 7’s medical record was reviewed. The document titled “(ED) care timeline” and “ED physician note” for the ED Visit dated 3/28/24 indicated Pt 7 returned to ED on 3/29/24 at 9:12 p.m. (30 hours and 54 minutes after discharge) with chief complaint of high glucose level and blurred vision. Vitals signs on arrival to ED on 3/29/24 at 9:18 p.m. indicated, pulse 120 beats per minute (bpm-normal 60-100 bpm), respiratory rate 20 breaths per minutes (normal 12-20), blood pressure 146/93 millimeters of mercury (mmHg-normal- less than 120/80 mmHg). Pt 7 was triaged at 9:35 p.m. on 3/29/24. Pt 7 was assigned an ESI level 3. The EDD stated the ESI should have been at 2 as the Pt 7 had high heart rate, blurred vison, and high blood pressure upon arrival to ED triage. The record reflected Pt 7’s primary assessment was completed by nurse at 9:40 p.m. on 3/29/24. A physician was assigned at 9:59 p.m. and orders were placed for labs & medication - sodium chloride 0.9 % bolus 1,000 mL IV. The venous blood gas (test of measurement of how much carbon dioxide are in your blood and to determine the acidity of your blood) was completed on 3/29/24 at 11:07 p.m. and results at 11:23 p.m. indicated pH (acidity/alkalinity (acid neutralizing capacity - opposite of acidity) of blood), Ven: 7.13 pH (normal range: 7.32-7.42), pCO2 Ven (measurement of carbon dioxide in venous blood): 35 (normal range: 41-51), pO2 Ven (measurement of oxygen in venous blood):<25 mm Hg (millimeter of mercury - Unit of measurement for pressure) (normal range:25-40), HCO3 Venous (test determines the amount of bicarbonate in the blood which is used to diagnose electrolyte imbalances, acidosis, or alkalosis): 11.3 mmol/L (millimoles per litre- Unit of measurement) (normal range 40-85), Base Excess Ven: -16.8 mmol/L ( normal range: -2.0 - 2.0). Sodium chloride bolus was administered to Pt 7 at 11:21 p.m. Lab results on 3/29/24 at 11:58 p.m. indicated Co2: 11 mmol/L, Glucose 287 mg/dL (normal range: 70-105) , Creatine (test to see how well kidneys are working) 1.32 mg/dL ( normal range: 0.50 - 1.20) , Total Protein (Test used to help diagnose kidney disease, liver disease, or nutritional problems) 8.2 (normal range: 6.1 -8.0). On 3/30/24 at 12:31 a.m. admitting physician was assigned and an order was placed to admit the patient to inpatient unit. The ED provider note on 3/29/24 indicated Pt 7 was admitted for diabetic ketoacidosis without coma (state of deep unconsciousness that lasts for a prolonged or indefinite period) associated with type 2 diabetes mellitus, dehydration (lose more fluid than you take in, and your body doesn’t have enough water and other fluids to carry out its normal functions. If you don’t replace lost fluids, you will get dehydrated) and tachycardia. During a review of the facility’s policy and procedure (P&P) titled, “Emergency Care Services - Index No. C-7)”, with a revised date of February, 2024, the P&P indicated, “ ...All patients discharged from the Emergency Department will receive appropriate discharge instructions, including information regarding any necessary follow up care and instructions on medication, devices and diagnosis ...The Nurse will involve other resources deemed necessary to facilitate a safe patient discharge, including ...initiating referral to social worker ...Document vitals within 30 minutes of discharge unless otherwise directed by Emergency Department Provider ...” During a review of the facility’s policy and procedure (P&P) titled, “Health System Policy A-11 - Emergency Medical Treatment and Labor Act (EMTALA) compliance” dated July, 2023, the P&P indicated “ ...any individual who comes to [facility name] (the “hospital”) seeking an examination and treatment of a potential emergency medical condition will receive a screening examination to determine the existence of any emergency medical condition, necessary stabilizing treatment for any emergency medical condition ...The hospital will provide an [Medical Screening Examination- A examination conducted by a physician or qualified medical personal to determine whether an individual have an emergency medical condition] within the capability of the Hospital for purposes of determining whether emergency medical condition (EMC) exits ...If EMC exists, the Hospital Shall: provide further examination and treatment , with in the capability of the Hospital, until the individual’s condition is stabilized; or provide for an appropriate transfer of unstabilized individual to another facility ...” 4. During a concurrent interview and record review on 4/18/24 at 10:35 a.m. with the Emergency Department Manager (EDM) 2 & EDM 3, Pt 11’s “Emergency Department (ED) care timeline” and “ED physician note” dated 4/17/24 was reviewed. The “Emergency Department (ED) care timeline” and “ED physician note” for the ED Visit dated 4/17/24 indicated Pt 11 was a 60-year-old female with the medical history of diabetes mellitus (disease of inadequate control of blood levels of glucose) and hypertension (high blood pressure) was sent to the ED by their primary care physician (PCP) due to elevated blood glucose level and possible pneumonia (infection of lungs). The ED physician note indicated Pt 11 stated to ED physician that her blood glucose level was in 600s at her PCP’s office. Pt 11 arrived in ED on 4/17/24 at 5:33 p.m. Pt 11’s electronic medical record indicated her first documented vital signs at 5:39 p.m. indicated her heart rate 107 beats per minute (bpm) (normal range 60 -100), respirations 18 breaths per minute (normal range 12-20), blood pressure 147/ 82 millimeters of mercury (mmHg - unit of measurement normal 120/80). Pt 11’s triage was completed on 4/17/24 at 6:00 p.m. and Pt 11 was assigned an emergency severity index (ESI- a 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious) of 2. Pt 11’s pain assessment was completed on 4/17/24 at 6:00 p.m. and Pt 11’s pain score was 5. Pt 11’s primary assessment was completed by the nurse on 4/17/24 at 6:02 p.m. Pt 11 was seen by provider at 6:29 p.m. On 4/17/24 at 6:33 p.m. orders were placed for labs that includes CBC and differential (CBC- blood test that measures many different parts often used to help screen overall health and measures the number of types of blood cells), Basic metabolic panel (BMP- test to check the body’s fluid balance and levels of essential minerals that are vital to key functions in the body), Troponin I high sensitivity (a test to measure a protein that is released during heart attack) , Hepatic function panel (groups of blood tests that provide information about the state of a patient’s liver), Urinalysis with microscopic reflex (test that measures chemical constituents of urine), Beta Hydroxybutyrate (test to detect ketones - a type of chemical that liver produces when it breaks down fats- use to diagnosis and monitoring complications of diabetes), B-type natriuretic peptide (blood test that measures levels of a protein called BNP, higher level in heart failure), Chest x-ray (an imaging test that looks at structures and organs in the chest) and electrocardiogram (EKG - test to record the electrical signals in the heart). Pt 11’s pain assessment on 4/17/24 at 7:50 p.m. indicates pain score at 7. Pt 11 was started on sodium chloride (use to replenish lost water and salt in body) 1000ml intravenous (IV- in the vein) on 4/17/24 at 7:56 p.m. Pt 11’s vitals on 4/17/24 at 8:17 p.m. indicated heart rate 105 bpm (normal 60-100), respirations 19 breaths per minute (normal 12-20), blood pressure 135/75 mmHg (normal less than 120/80 mmHg). The urinalysis results on 4/17/24 at 8:20 p.m. indicated urine glucose level (indicating blood glucose level is high) > 500 mg/dL (milligrams (mg) per deciliter (dL)- unit of measurement). (normal range: Negative), Ketones, urine (indicate diabetic ketoacidosis -DKA): 20 mg/dL (normal range: Negative). The results for BMP on 4/17/24 at 8:39 p.m. indicates Sodium (help find and monitor conditions that affect the balance of fluids, electrolytes, and acidity in your body): 132 mmol/L (normal range : 135-145), Chloride (help balance electrolyte and low level indicate dehydration): 96 mmol/L (normal range 98-114), Glucose: 351 mg/dL (normal range: 70-105), BUN/Creatinine Ratio (Blood Urea Nitrogen (BUN)/Creatinine ratio indicates an imbalance in the kidney’s ability to filter and remove waste) 35.2 (normal range 10.0-20.0). The results for Hepatic Function on 4/17/24 at 8:39 p.m. indicated Total protein (high level indicate dehydration) 8.1 g/dL (normal range 6.1-8). The lab results on 4/17/24 at 8:39 p.m. for Beta-Hdroxybutyrate: 0.35 mmol/L (normal range: 0.02-0.27) Pt 11’s vitals were completed on 4/17/24 at 10:06 p.m. indicates Heart rate 100 bpm (60-100 bpm), respirations 19 (normal 12-20) breaths per minute, Blood pressure 147/89 mmHg (normal less than 120/80). Pt 11’s pain assessment was completed on 4/17/24 at 10:33 p.m. and Pt 11’s pain score was 5, note by RN indicated “pt states pain is tolerable”. Pt 11 was discharged on 4/17/24 at 10:38 p.m. Pt 11’s “Emergency Department (ED)” care timeline did not indicate a recheck of Pt 11’s blood glucose prior to discharge. During a review of the document titled, “ED Physician note”, dated 2/23/24, the ED physician note indicated, “ ... 60- year- old woman with history of type 2 diabetes ( body cells don’t respond normally to insulin produced by your body) who is referred by her primary care doctor for hyperglycemia (high blood glucose level). While she was at the clinic, they note her [blood glucose] to be greater than 500. She is currently taking glipizide (medication taken for diabetes) for her diabetes and does not take any thing else. She reportedly is compliant on her medications. On examination she is well appearing without any vomiting or neurological (nervous system - Brian, spinal cord, and a complex network of nerves) deficits. Vital signs [BP & heart rate] stable. Glucose check today is 350. She was given 1-liter normal saline bolus. Remainder of her labs were all from unremarkable including no evidence of [Diabetic Ketoacidosis - a complication of diabetes in which acids build up in the blood to a level that can be life threatening]. Normal anion gap (measures the difference-or gap-between the negatively charged and positively charged electrolytes in your blood). Unremarkable electrolytes. No evidence of [high white blood cells] or [condition that develops when your blood produces a lower-than-normal amount of healthy red blood cells]. Patient was recommended to follow up with the PCP for medication adjustment as needed and to remain compliant on her medication. Return indication discussed ...She also had a concern for possible pneumonia (infection of lungs) given her cough, this was evaluated with a chest -xray which was normal as well ...Plan to discharge ...” During an interview on 4/18/24 at 10:40 a.m. with the EDM 2, EDM 2 stated he has reviewed the medical record of Pt 11 for the ED visit for 4/17/24. EDM 2 stated Pt 11’s blood glucose was only checked on BMP results on 4/17/24 at 8:39 p.m. EDM 2 stated no physician order to check blood glucose level prior to discharge. EDM 2 stated he would have expected a blood glucose check done prior to discharge. The EDM 2 stated Pt 11 received a fluid bolus (with 1000 ml of sodium chloride) in ED, Pt 11 was here due to high blood glucose level and without having a blood glucose value reevaluated at discharge, EDM2 did not want to comment if the blood glucose was acceptable for discharge. During an interview on 4/18/24 at 2:37 p.m. with the Emergency Department Director (EDD), the EDD stated it was her expectation that any diabetic patient that presented to ED with high or low blood glucose level, and received treatment for it in ED should have their blood glucose checked along with vitals prior to discharge. The EDD stated it was important to check the blood glucose prior to discharge to ensure that diabetic patients were stabilized for discharge. The EDD stated Pt 11 was in the ED for high blood glucose, sent in by her PCP that was concerned for high blood glucose levels and Pt 11 should have had her blood glucose checked prior to discharge. 49538 5. During a review of the hospital’s report of returns to the ED within 48 hours (of a previous ED visit) and ED Log (the hospital’s record of every patient who comes to the ED), for January 2024, was reviewed. The ED Log indicated Patient (Pt) 9 was a 73-year-old male who came to the ED on 1/9/24 at 4:31 p.m. with a chief complaint of “Shortness of Breath” and was discharged on 1/10/24 at 1:27 a.m. The ED Log indicated Pt 9 returned to the ED on 1/11/24 at 12:51 p.m. with a chief complaint of “Shortness of Breath” and was admitted for an elevated troponin level, a thoracentesis procedure, and continue PD in the hospital. During a concurrent interview and record review on 4/11/24 at 9:06 a.m. with Emergency Department Manager (EDM ) 2, Pt 9’s “Patient Care Timeline (PCT)” , dated 1/9/24 was reviewed. EDM 2 stated Pt 9 arrived in the ED on 1/9/24 at 4:31 p.m. by car with a family member. The PCT indicated at 4:31 p.m., “ ...Arrival complaint ...chest pain ...” EDM 2 stated an electrocardiogram (EKG- a test to record the electrical signals in the heart and shows how the heart is beating) was ordered at 4:34 p.m. and performed at 4:40 p.m. EDM 2 stated the EKG should have been completed, reviewed and signed by a physician within ten minutes of Pt 9’s arrival to the ED. EDM 2 stated there was no indication in the electronic medical record (EMR) that the physician reviewed and signed the EKG results for Pt 9 on 1/9/24 at 4:40 p.m. EDM 2 stated Pt 9 was placed back in the lobby after the EKG was performed. EDM 2 stated he expected the EKG technician to print out the EKG results, give the results to the physician for review and signature, place it in a file to be scanned and uploaded into the Pt 9’s EMR. EDM 2 stated the EKG result would be scanned into Pt 9’s chart after it was reviewed by the physician. EDM 2 stated this was not completed for Pt 9. During a concurrent interview and record review on 4/11/24 at 9:10 a.m. with EDM 2, Pt 9’s PCT, dated 1/9/24 was reviewed EDM 2 stated Pt 9 was triaged at 4:42 p.m. and the triage RN indicated “ ...Chest pain for 4 days. [History] of [myocardial infarction (MI-a heart attack)] 2004, [coronary artery bypass graft (CABG- a medical procedure to improve blood flow to the heart)]. Pain increases [with] movement. Hurts to cough, [non-productive] ...” The PCT indicated Pt 9’s chief complaint was updated 1/9/24 at 4:44 p.m. to “ ...Shortness of Breath (Sob and chest wall pain on inspiration (allows air to flow into the lungs) ...” EDM 2 stated Pt 9 was given an ESI level of 3. EDM 2 stated Pt 9 should have been assigned an ESI level of 2 given Pt 9’s history of MI and CABG. EDM 2 stated Pt 9’s ESI level was changed to 2 at on 1/9/24 at 5:45 p.m. During a concurrent interview and record review on 4/11/24 at 9:15 a.m. with EDM 2, Pt 9’s PCT, dated 1/9/24 was reviewed. EDM 2 stated Pt 9’s vital signs were taken 1/9/24 at 4:45 p.m. which indicated a heart rate of 81 beats per minute (bpm; normal range 60-100 bpm) and blood pressure of 122/88 millimeter of mercury (mmHg-normal is less than 120/80mmHg). EDM 2 stated Pt 9 had “normal” vital signs at 4:45 p.m. and was “not tachycardic (heart rate above 100 bpm) or hypoxic (having too little oxygen)”. EDM 2 stated Pt 9’s next set of vital signs could be taken in four hours. EDM 2 stated 1/9/24 at 8:23 p.m., the ECT obtained Pt 9’s vital signs and the heart rate was 81 bpm and blood pressure was 88/66 mmHg, a time lapse of 3 hours and 37 minutes after the first set of vital signs. EDM 2 stated there was a drop in the blood pressure and a reassessment of the vital signs was not completed. EDM 2 stated he expected the Emergency Clinical Technician (ECT) to notify the nurse for a drop in blood pressure. EDM 2 stated there was no documentation a nurse was notified of Pt 9’s blood pressure on 1/9/24 at 8:23 p.m. EDM 2 stated the vital signs should had been reassessed within one hour since there was a drop in the blood pressure. EDM 2 stated the next completed vital signs were taken on 1/10/24 at 1 a.m. (4 hours and 37 minutes later). EDM 2 stated vital signs were taken 3.5 to 4.5 hours apart and should have been taken every two hours. EDM 2 stated the policy indicated a patient with an ESI level of 3 should have vital signs completed every two hours and if vital signs were normal, vital signs would be completed every four hours. During a concurrent interview and record review on 4/11/24 at 9:30 a.m. with EDM 2, Pt 9’s PCT, dated 1/9/24, and “Computed Tomography (CT) Angio Chest/Abdomen/Pelvis (CAP)” report, dated 1/9/24, were reviewed (continued review). EDM 2 stated a MSE was initiated on 1/9/24 at 5:37 p.m. (57 minutes after EKG was performed). EDM 2 stated the physician placed orders for labs and a CT (a diagnostic imaging procedure that uses a combination of X-rays and computer technology to produce images of the inside of the body) of the chest, abdomen, and pelvis with contrast. The PCT indicated, “[5:40 p.m.] Orders Placed ...Lab ...Troponin I high sensitivity; B-type natriuretic peptide (BNP-a blood test that measures levels of a protein called BNP that is made by your heart and blood vessels) ...[7:27 p.m. BNP] resulted ...Abnormal Result ...819 [picograms per milliliter (pcg/mL-unit of measure)] (Ref Range: 0 - 100) ...[7:33 p.m.] Troponin I high sensitivity Resulted ...Abnormal Result ...58 [nanograms per liter (ng/L-unit of measure)] (Ref Range: 0 - 20) ...” EDM 2 reviewed the EMR and was unable to locate if the physician had interpreted Pt 9’s troponin lab results. EDM 2 stated Pt 9 was roomed at 10:18 p.m. (5 hours and 47 minutes after arrival) for a peripheral IV insertion (IV-a small, short plastic catheter that is placed through the skin into a vein) and then moved to the “waiting area for CT”. EDM 2 stated Pt 9 had a CT performed at 11:39 p.m. The CT Angio CAP report indicated, “ ...Moderate right pleural effusion (a buildup of fluid between the tissues that line the lungs and the chest) ...” During a concurrent interview and record review on 4/11/24 at 9:45 a.m. with EDM 2, Pt 9’s “ED Provider Notes (EPN),” dated 1/9/24 was reviewed. The EPN indicated, “ ...[patient] was seen at Urgent Care today where an [x-ray] was obtained ...[Patient] reevaluated at bedside. Gets peritoneal dialysis at home. Would like to be discharged for that and to return tomorrow for a paracentesis (a procedure to remove fluid buildup inside your abdomen) ... [Patient] reevaluated at bedside. Case, labs, [CT Angio], and EKG reviewed, informed of [end stage renal disease] and pleural effusion diagnosis. Advised to follow up with primary care provider and to return for paracentesis ...[Patient] understands and agrees with the treatment plan ...” EDM 2 stated there was no appointment scheduled for a paracentesis for the next day. During a review of Pt 9’s “Office Visit (OV),” for the hospital dated 1/9/24, the OV indicated, “ ...Office Visit ...Urgent Care ...Patient presents with ...Chest Pain ...over the past 3 to 4 days has had increasing pain in his right chest area associated with progressive shortness of breath and dyspnea on exertion. He describes a sharp right chest pain worse with coughing ...Discussed options and the patient is getting progressively worse so suggested probably ED consult for further imaging as indicated, as well as possible drainage ...” During a concurrent interview and record review on 4/11/24 at 10 a.m. with EDM 2, Pt 9’s PCT, dated 1/9/24 was reviewed. The PCT indicated Pt 9 had a discharge order on 1/10/24 at 12:18 a.m. EDM 2 stated Pt 9’s vital sign before discharge was completed at 1 a.m. which indicated Pt 9 had a heart rate of 46 bpm which was below the normal range of 60 bpm and no pain assessment was completed. EDM 2 stated a pain assessment should had been completed at discharge as it is part of the facility’s vital signs. EDM 2 stated an order for an EKG was placed at 1:14 a.m. and performed at 1:15 a.m. EDM 2 stated he was not able to locate the reviewed and signed physician results of Pt 9’s EKG results on 1/10/24 at 1:15 a.m. in the EMR. EDM 2 stated he expected the vital signs be reassessed after the EKG was performed due to the concerning heart rate. EDM 2 stated Pt 9 was discharged on 1/10/24 at 1:27 a.m. in good condition, in a wheelchair with his significant other. During a concurrent interview and record review on 4/11/24 at 12:10 p.m. with EDM 2, Pt 9’s PCT, dated 1/9/24 was reviewed. EDM 2 stated the ECT had taken Pt 9’s vital signs at 8:23 p.m. in the lobby. EDM 2 stated the ECT should have notified the triage RN about the low blood pressure. EDM 2 stated it was ultimately the RN’s responsibility to review the patient’s EMR and vital signs and notify the physician. EDM 2 stated the physician order for troponin lab draw was ordered for one occurrence on 1/9/24 and there was no order for a second troponin lab draw. During an interview on 4/11/24 at 12:15 p.m. with EDM 2, EDM 2 stated the facility had RNs who were trained to perform dialysis. EDM 2 stated there was no documentation when Pt 9 had last received PD. EDM 2 stated Pt 9 was not offered PD services in the hospital. EDM 2 stated it was the RN’s responsibility to assess and document when the patient last received PD. During a concurrent interview and record review on 4/11/24 at 12:20 p.m. with EDM 2, Pt 9’s PCT, dated 1/11/24 was reviewed. EDM 2 stated Pt 9 returned to the ED on 1/11/24 at 12:50 p.m. The PCT indicated at 12:51 p.m., “ ...Arrival Complaint ...Recheck/called by ER [doctor] ...” EDM 2 stated Pt 9 was triaged and given an ESI level of 3 at 1:26 p.m. with a chief complaint of “Shortness of Breath (Sob and chest pain. Told to return by [MD 2] to have fluid drained from lungs).” EDM 2 stated a MSE was initiated at 1:34 p.m. EDM 2 stated MD 3 placed orders for a chest x-ray and EKG at 1:35 p.m. EDM 2 stated Pt 9 was roomed at 1:40 p.m. The PCT indicated Pt 9 had an IV insertion at 1:47 p.m. to the left forearm. During a concurrent interview and record review on 4/11/24 at 12:30 p.m. with EDM 2, Pt 9’s PCT, dated 1/11/24 was reviewed. EDM 2 stated Pt 9 received fentanyl (a type of pain medication) 50 micrograms (mg-unit of measure) through his IV at 1:51 p.m. and no initial pain assessment was completed when pain medication was administered. EDM 2 stated the pain assessment was completed at 1:56 p.m. (5 minutes after pain medication was administered). EDM 2 stated Pt 9 complained of pain to his “upper right chest wall” on his back. EDM 2 stated Pt 9 had a pain score of eight which indicated severe pain on a scale of 0 to 10 (0-3 mild pain, 4-6 moderate pain, 7-10 severe pain). EDM 2 stated RN 12 did not associate a pain when the medication was scanned in the EMR. EDM 2 stated he expected the staff to complete a pain assessment when the pain medication was scanned in the EMR. EDM 2 stated a pain reassessment was not completed after Pt 9 received pain medication. EDM 2 stated it was important to reassess Pt 9’s pain level to determine if the intervention was effective. EDM 2 stated the pain assessment should have been completed 30 minutes after the fentanyl was administered. EDM 2 stated the next pain assessment for Pt 9 was at 8 p.m. (6 hours and 4 minutes later). EDM 2 stated Pt 9 had a pain score of zero which indicated no pain on a scale of 0 to 10. During a concurrent interview and record review on 4/11/24 at 12:40 p.m. with EDM 2, Pt 9’s PCT, dated 1/11/24 was reviewed. The PCT indicated, “ ... [1:35 p.m.] Orders Placed ...Medications - fentanyl injection 50 mcg ...Lab ...Troponin I high sensitivity ...Imaging - XR Chest ...ECG ...[1:48 p.m.] Order Performed ...ECG ...[1:52 p.m.] Imaging Exam Started XR Chest ...[2:42 p.m.] Troponin I high sensitivity resulted ...Abnormal Result ...61 ng/L ...” Pt 9 had an ECG performed at 1:48 p.m. The PCT indicated Pt 9 had a chest x-ray performed at 1:52 p.m. EDM 2 stated Pt 9 received admission orders at 3:50 p.m. EDM 2 stated Pt 9 was admitted for pleural effusion. During a review of Pt 9’s EPN, dated 1/11/24, the EPN indicated, “ ...presents to the ED due to SOB, cough, and chest pain a couple of days ...States his cough has become more severe since he was last seen in the ED ...return today ...to have fluid drained from his lungs ...return by the direction of his previous physician to have a thoracentesis ...Patient was ultimately admitted ...will continue peritoneal dialysis ...” During a review of the facility’s policy and procedure (P&P) titled, “Emergency Department Arrival (Triage), Documentation, and Discharge,” revised February 2024, the P&P indicated, “ ...Vital Signs ...2. ESI Level 2: Document at least every 2 hours or more frequently based on clinical condition ...3. ESI Level 3: Document every 2 hours. If normal vital sign trends or clinically stable (a minimum of 2 sets of vital signs within normal limits) document at least every 4 hours ...6. Developmentally appropriate, pain scale shall be documented along with ongoing vital signs and [as needed]. 7. Abnormal vital signs are to be reassessed with subsequent notification to primary RN or provider ...” During a review of the facility’s P&P titled, “Pain Management Guidelines,” revised November 2020, the P&P indicated, “Patients are timely assessed/re-assessed for pain ...8. Pain will be reassessed and documented 15 minutes after IV pain medicine administration ...PROCEDURE: ...1. Assess and reassess pain at regular intervals appropriate for the specific patient including: ...D. Following pain management interventions, once sufficient time has elapsed for the treatment(s) to be effective. E. Prior to discharge ...” During a review of a professional reference retrieved from: https://www.ahajournals.org/doi/10.1161/CIR.0000000000001029#d1e1610 , titled, “2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guidelines for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines,” the reference indicated, “ ...The goals in patients presenting to the ED or office with acute chest pain are: 1) identify life-threatening causes; 2) determine clinical stability; and 3) assess need for hospitalization versus safety of outpatient evaluation and management...The 12-lead ECG, which should be acquired and interpreted within 10 minutes of arrival to a medical facility, is pivotal in the evaluation because of its capacity to identify and triage patients with STEMI to urgent coronary reperfusion... “”